An ice pack or cool compress may also help. A 50% reduction was cited by Supakatisant C, Phupong V, reference number 16 (Oral magnesium for relief in pregnancy-induced leg cramps: a randomised controlled trial. Magnesium supplements may also interact with some medications, including antibiotics and diuretics (2). At baseline, 74 (56.3%) had two leg cramps episodes per week, 28 (21.1%) three episodes, 13 (9.8%) four episodes and 9 (6.8%) five or more episodes. For missing value: In your flwo chart, all 66*2 were included into your analysis, however, in your table 2 only 64 in treatment and 64 in control group were included into analyses. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". These 11 pregnant women (2 in the intervention group and 9 in the control group) were now included in the analysis and the ratio 1:1 restored. Magnesium can help your mind relax and your body achieve deep, restorative sleep. DYSPEPSIA Another common condition with several self-treatment options is dyspepsia, a key symptom of gastroesophageal reflux disease (GERD). This double-blinded, randomised, placebo-controlled trial included 86 healthy pregnant women, 14-34 weeks of gestation who had leg cramps at least twice per week. The sample size was calculated based on 50% reduction of leg cramps. This limitation was added in the discussion: 4) Because this study was observational, it could be prone to biases. Doses of 250 mg of magnesium supplements daily have been shown to improve blood glucose levels in patients with diabetes, but more research is needed. Each pack was individually prescribed for each participant. In table 2, 27,2 should be 27.2. Why Is Magnesium Important During Pregnancy? In fact, older studies in rats have shown that suboptimal magnesium levels led to poor sleep quality (18). 8600 Rockville Pike Magnesium citrate and magnesium hydroxide are common magnesium compounds used to treat constipation. Indiana University Richard M Fairbanks School of Public Health, UNITED STATES. h. Jun 11, 2023 at 2:25 AM. eCollection 2020. The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Answer: We apologize for this mistake. Exceeding the recommended intake could cause watery diarrhea or electrolyte imbalances (16). Methods This observational clinical trial studied 132 pregnant women with leg cramps in the first trimester of pregnancy. 2. The rationale for the trial requires more explanation in the introduction to highlight any gaps in knowledge. The sample size of the initial study is based on the primary outcome (perinatal composite outcome). Magnesium is found naturally in foods like nuts, leafy green vegetables, and milk products (2). The reference Currently the 20% dropout rate is a little bit large. the contents by NLM or the National Institutes of Health. PLOS authors have the option to publish the peer review history of their article (what does this mean?). 3) abstract says the 2 groups were comparable. 3. -, Zhou K, West HM, Zhang J, Xu L, Li W. Interventions for leg cramps in pregnancy (Review). The site is secure. This study was part of the Brazil MAGnesium trial [13] and registered at ClinicalTrials.gov (Identifier {"type":"clinical-trial","attrs":{"text":"NCT02032186","term_id":"NCT02032186"}}NCT02032186). Please see below the point-by-point responses to the reviewers specific comments. The site is secure. 4. Best for migraine: Douglas Laboratories Magnesium Oxide. Magnesium is involved in more than 300 biochemical reactions in your body and crucial for maintaining good health (41). We look forward to receiving your revised manuscript. 2020 Oct 22;7:2054358120964078. doi: 10.1177/2054358120964078. The salt form [e.g., magnesium chloride, magnesium gluconate, etc.] Careers. While magnesium supplements may improve depression in those with magnesium deficiency, further research is needed to know if they can alleviate depression in those with normal magnesium levels. The most important thing to consider before deciding on a supplement is its absorption rate, or how well the supplement is absorbed by your body. Cochrane Database Syst Rev. we need some measure of the absolute, not only relative, reduction. 6. Insulin is a hormone that helps control blood sugar levels by signaling your cells to take in sugar from your blood. There were no significant differences between the two groups in terms of side effects such as nausea and diarrhoea. Outcome measure was the reduction of cramp frequency after treatment and cramp intensity measured by 100-mm visual analogue scale. The sample size calculation was based on the estimation of 50% reduction in frequency of leg cramp in Mg treatment group. FOIA However, low magnesium intake is relatively common. The effects were now quantified in ORs. HHS Vulnerability Disclosure, Help At baseline, 74 (56.0%) had two leg cramps episodes per week, 28 (21.2%) three episodes, 7 (9.8%) four episodes and 23 (13.0%) five or more episodes; 66 pregnant women were assigned to the Mg++ group (300 mg per day) and 66 were assigned to the placebo (Fig 1). The pregnant women in this study had a magnesium serum level in the minimum limit of normality (1.8 mg/dl) and around half of participants had hypomagnesemia. 5: Exclusion of those with Mg at baseline >9.5mmol/dL is not physiologically plausible given the Mg reference range. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. 8.) (Please upload your review as an attachment if it exceeds 20,000 characters), Reviewer #1: I will focus on methods and reporting. MagTech. HHS Vulnerability Disclosure, Help Magnesium hydroxide, also known as milk of magnesia, is commonly used as a laxative to treat constipation and in some antacids to treat heartburn (2, 12). Moreover, another study found that taking 305 mg of magnesium (from 500 mg of magnesium oxide) for 8 weeks led to significant improvements in symptoms of depression in people with low magnesium levels (32). Hall H, Lauche R, Adams J, Steel A, Broom A, Sibbritt D. Healthcare utilisation of pregnant women who experience sciatica, leg cramps and/or varicose veins: A cross-sectional survey of 1835 pregnant women, The importance of magnesium in clinical healthcare, Magnesium: The Forgotten Electrolyte-A Review on Hypomagnesemia. Magnesium therapy does not appear to be effective in the treatment of NLC in the general population, but may have a small effect in pregnant women. 1 In table 2, 27,2 should be 27.2. Exclusion criteria were uncontrolled known hyperthyroidism, any type of known active parathyroid disease, chronic diarrheal disease, chronic kidney disease, defined by an estimated glomerular filtration rate below 60 mL / min / 1.73 m2, as determined by the initial assessment or by known history, Mg ++ serum concentration at baseline > 2.6 mg / dL. eCollection 2020. When submitting your revision, we need you to address these additional requirements. Background: Leg cramps are a common problem in pregnancy. pg. The standard dose for magnesium citrate is 240 milliliters (mL) per day, which can be mixed with water and taken orally. Oral magnesium supplementation during pregnancy did not reduce the ocurrence and frequency of episodes of leg cramps. I am sorry to say, but from my point of view there are unsurmountable methodological deficits. {"type":"clinical-trial","attrs":{"text":"NCT02032186","term_id":"NCT02032186"}}, {"type":"clinical-trial","attrs":{"text":"NCT 02032186","term_id":"NCT02032186"}}, Interventions for leg cramps in pregnancy (Review), Lower extremity changes experienced during pregnancy. Follow your doctor's orders or the directions on the label. Besides insufficient magnesium intake is common, especially in low-income regions [9]. Still, more research is needed, as several other studies have found no effect of magnesium supplements on leg cramps (27, 28, 29). If published, this will include your full peer review and any attached files. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. Without allocation concealment, randomization would be unsuccessful. Oral magnesium supplementation for leg cramps in pregnancy-An observational controlled trial PLoS One. The included studies ranged from 14 to 56 days of treatment. Premenstrual syndrome (PMS) is a group of symptoms, including water retention, agitation, and headaches, that many experience about 12 weeks before their period (35). Last medically reviewed on December 16, 2022. Interventions for leg cramps in pregnancy. Ionic-Fizz Magnesium Plus. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The PLOS ONE style templates can be found at, http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. But the causes of leg cramps are wide-ranging. 13.) Another 2010 study found that supplementing with 250 mg of magnesium helped relieve PMS symptoms more effectively when combined with 40 mg of vitamin B6 (37). Allocation concealment was ensured, as the referred researcher did not release the randomization code until the participants were recruited into the trial after all baseline measurements were completed. 1. Thank you for submitting your work to PLOS ONE. Does it work? ( Up to 75. Since magnesium is key to muscle function, a deficiency may cause painful muscle contractions. Therefore, oral magnesium may be a treatment option for women suffering from pregnancy-induced leg cramps. Studies have found that magnesium oxide is essentially insoluble in water, making absorption rates low (9). Answer: The study was now identified as an observational trial. Secondary outcomes were the ocurrence of leg cramps and oral magnesium side effects. However, there are still no consistent conclusions for treating leg cramps in pregnancy. People who experience migraines may be at risk of magnesium deficiency due to several factors, including a genetic inability to absorb magnesium efficiently or increased excretion of magnesium due to stress (38). Alertness and awareness problems. The study was approved by the IMIPs Committee on Research (document number 4033), and was registered in the ClinicaTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT 02032186","term_id":"NCT02032186"}}NCT 02032186). 2) information on the blinding is needed in title and/or abstract. When you are ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Alves JG, de Arajo CA, Pontes IE, Guimares AC, Ray JG. Answer: The flowchart was corrected. Magnesium is a very important nutrient that most people don't get enough of. The current sample size might not be sufficient for detecting the differences in the primary outcome, since they calculated it according to the frequency of leg cramp. Funded by the Bill & Melinda Gates Foundation (OPP1107597) and Conselho Nacional de Desenvolvimento Cientfico e Tecnlogico, CNPq (401609-2013-8). Therefore, the sample size and corresponding power is not adequate for the current outcome (presence of leg cramps) and puts the validity of the analysis and subsequent conclusion into question. government site. Careers, Unable to load your collection due to an error. In one older animal study, it was shown to have the highest absorption rate among other types of magnesium supplements (8). Its crucial for many functions in your body, including energy metabolism and protein synthesis. @Nili, Currently, there is no standard treatment for pregnancy-induced leg cramps. The OR of leg cramps was 1.3 (CI 95%: 0.62.9), p = 0.527, taking the placebo group as reference. They were randomized 1:1 to 300 mg/day of oral Mg++ citrate (n = 66) or placebo (n = 66). Three serum levels are listed: should one be deleted? The https:// ensures that you are connecting to the The study is merely an observational trial. Provide information on whether any stopping rules were instituted (CONSORT missing item). The 50% reduction of cramp intensity was also significantly higher in the treatment group than in the placebo group (69.8% vs. 48.8%, P=0.048). Systematic reviews have used frequency of leg cramps as a primary outcomes. Consenting pregnant women received a 4 weeks magnesium citrate capsule (300 mg elemental magnesium citrate per capsule) or a daily placebo capsule identical in colour and shape. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. There are many critical design flaws for this study. Your manuscript is now with our production department. We would appreciate receiving your revised manuscript by Dec 23 2019 11:59PM. Reviewer #3: 1. Histogram of percentage change of number of leg cramps. All the database was reviewed with a biostatistician and it was observed that eleven 18-year-old pregnant women had not been included in the analysis. Even if perfectly balanced why did they not analyse in the context of a logistic regression, where the effects could be quantified in ORs? The dose medicines in this class will be different for different patients. IMIP registers about 6,000 deliveries per year. Is It Safe to Take Magnesium When Pregnant? The CONSORT checklist does not longer correspond to the presented study. Does oral magnesium substitution relieve pregnancy-induced leg cramps? I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Magnesium supplementation in pregnancy (Review), Effect of magnesium therapy on nocturnal leg cramps: a systematic review of randomized controlled trials with meta-analysis using simulations. The current sample size might not be sufficient for detecting the differences in the primary outcome, since they calculated it according to the frequency of leg cramp. With adjustments for a withdrawal rate of 10%, a minimum of 66 women in each group were required. Nygaard IH, Valbo A, Pethick SV, Bohmer T. Does oral magnesium substitution relieve pregnancy-induced leg cramps? Forty-one women were assigned to magnesium bisglycinate chelate (300 mg per day) and 39 women to placebo. Its recommended to only take a daily magnesium supplement that provides more than 350 mg while under medical supervision. A Cochrane review on leg cramps in pregnancy showed some potential benefits in trials of magnesium. We note that you have indicated that data from this study are available upon request. The .gov means its official. Magnesium therapy has been shown to be effective in eclampsia-related seizures [6]. These results demonstrated that oral magnesium supplement can improve the frequency and intensity of pregnancy-induced leg cramps. In addition, the definition of leg cramps was not well stablished in some studies. The Food and Nutrition Board of the United States Government's Office of Dietary Supplements sets the suggested daily consumption of magnesium at 270 to 400 mg for men and 280 to 300 mg for women. Oral magnesium supplementation for leg cramps in pregnancy a randomized controlled trial. Randomised, cross-over, placebo controlled trial of magnesium citrate in the treatment of chronic persistent leg cramps. As a library, NLM provides access to scientific literature. The method for missing values were not mentioned in the study. Adequate magnesium levels are important for a good nights sleep. Although magnesium deficiency has been implicated with an increased risk for gestational and adverse perinatal outcomes, there is not enough high-quality evidence to show that dietary magnesium supplementation during pregnancy is beneficial. Answer: This information was added in the abstract. Though research on magnesium supplements for muscle cramping is mixed, one older study found that participants who received 300 mg of magnesium daily for 6 weeks reported fewer muscle cramps compared with those who received a placebo (25). The .gov means its official. 2020 Dec 4;12(12):CD010655. Among pregnant women who remained with leg cramps the mean of leg cramps episodes per week showed no significance difference between the Mg++ and placebo groups; t-student test: p = 0.408. A marked-up copy of your manuscript that highlights changes made to the original version. Would you like email updates of new search results? This limitation was included in the discussion. The RDA for magnesium for adults is 310420 mg, depending on age and sex. Non-drug therapies for the secondary prevention of lower limb muscle cramps. An official website of the United States government. Oral magnesium supplementation during pregnancy did not reduce the ocurrence and frequency of episodes of leg cramps. According to some older research, this is likely because its absorbed in a different area of your intestine compared with many other forms of magnesium supplements (14). Answer: The introduction was complemented. What is the odds ratio? Magnesium oxide has the highest amount of elemental, or actual, magnesium per weight. Unable to load your collection due to an error, Unable to load your delegates due to an error. On the other hand, it is uncertain whether oral magnesium supplementation reduces pregnancy-associated rest cramps as well as the safety profile of this intervention. Answer: Thank you for this observation. 3.For missing value: In your flwo chart, all 66*2 were included into your analysis, however, in your table 2 only 64 in treatment and 64 in control group were included into analyses. Reviewer #2: 2. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. Best for magnesium deficiencies: Trace . If you have any billing related questions, please contact our Author Billing department directly at gro.solp@gnillibrohtua. National Library of Medicine 4 5 This may include: Digestive system-related side effects, such as diarrhea, nausea, and stomach cramps. This is supposed to offer robustness to our results. All the database was reviewed with a biostatistician and it was observed that eleven 18-year-old pregnant women had not been included in the analysis. Many individuals use magnesium as a sleep aid, and its ability to induce muscle relaxation and ease stress are two of the main ways it's thought to help people fall asleep faster. Interventions for leg cramps in pregnancy. 14.) Magnesium 7. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the Comments to the Author section, enter your conflict of interest statement in the Confidential to Editor section, and submit your "Accept" recommendation. If you encounter any issues or have any questions when using PACE, please email us at gro.solp@serugif. The authors declare that they have no conflicts of interest. Please enable it to take advantage of the complete set of features! 8600 Rockville Pike gestational diabetes erythrocytes fetal growth retardation hypomagnesemia infant, small for gestational age premature obstetric labor mothers magnesium level Issue Section: Lead Article INTRODUCTION The manuscript has been completely revised and we hope it will be able to be published. Although further research is needed on magnesium and muscle cramps, taking 300 mg of magnesium daily may help decrease symptoms. In fact, taking a magnesium supplement may improve depressive symptoms in some people. 3. Answer: During the second trimester 70.0 % (91/130) of 130 participants that had leg cramps in the first trimester continued presenting leg cramps. The mean magnesium serum level was 1.84 mg/dL (CI 95%: 1.801.87) in the Mg++ group and 1.84 mg/dL (CI 95%: CI 1.801.87) in placebo group (t-Student test: p = 0.872). Gastrointestinal side effects were observed in a few women and there were no differences between the magnesium and placebo groups. and transmitted securely. Please re-check your numbers. 2.) Garrison SR, Allan GM, Sekhon RK, Musini VM, Khan KM. Secondary outcomes were the presence of leg cramps episodes and oral magnesium side effects. Best for leg cramps: MegaFood Magnesium. The record will include editor decision letters (with reviews) and your responses to reviewer comments. Various studies on magnesium supplements effects on exercise performance have found mixed results. This double-blinded, randomised, placebo-controlled trial inc Leg cramps are common in pregnant women. Here are the details: Pregnant women 18 and under: 400 milligrams (mg) per day Pregnant women ages 19 to 30: 350 mg per day Advertisement | page continues below Pregnant women ages 31 to 50: 360 mg per day For example, the Garrison et al. Federal government websites often end in .gov or .mil. Also, please provide your function for sample size calculation. eCollection 2020. If this link does not appear, there are no attachment files to be viewed.]. A Higher Concentration of Dialysate Magnesium to Reduce the Frequency of Muscle Cramps: A Narrative Review. High blood sugar levels can increase magnesium loss through urine, causing low magnesium levels in your blood. Why was a 50% reduction in leg cramps expected? Fanni D, Gerosa C, Nurchi VM, Manchia M, Saba L, Coghe F, Crisponi G, Gibo Y, Van Eyken P, Fanos V, Faa G. Biol Trace Elem Res. How common are cramps during the second trimester (study population used in the RCT)? Abstract. In contrast, for those experiencing pregnancy-associated rest cramps the literature is conflicting and further research in this patient population is needed. We studied pregnancy-associated cramps and our conclusion is the same of Garrison et al, i.e. The conclusions must be drawn appropriately based on the data presented. The study medication packages were supplied with sequential numbers. Inclusion in an NLM database does not imply endorsement of, or agreement with, 5) no information on baseline levels in the abstract - only the reduction. Our sample size was calculated based on the frequency of leg cramps which is the parameter most used in trials assessing leg cramps interventions. The BRAzil MAGnesium (BRAMAG) trial: a randomized clinical trial of oral magnesium supplementation in pregnancy for the prevention of preterm birth and perinatal and maternal morbidity. Pregnant women with different gestational ages were studied, interventions for variable periods of time (2 to 4 weeks) were used, different oral magnesium doses and oral formulations were administered. It was a typo error and it was corrected (2.6 mg/dL). However this evaluation includes a high degreee of subjectivity; 2) Magnesium serum level was not assessed after intervention; 3) Pregnancy women were studied in the first trimester of pregnancy but leg cramps is a more common problem in the third trimester; 4) Because this study was observational, it could be prone to biases. If you choose no, your identity will remain anonymous but your review may still be made public. Answer: Effects and their CIs were provided. Based on limited research, taking 320729 mg of magnesium daily may help you fall asleep faster. Another study noted the ability of magnesium supplements to reduce the frequency of leg cramps during pregnancy, reporting that those who took 300 mg of magnesium daily experienced less frequent and less intense leg cramps, compared with those who took a placebo (26). After 4 weeks of intervention it was observed a 28.4% (39/132) (CI 95%: 20.937.0) reduction of leg cramps in all participants and no difference between the two groups was found; reduction of 27.2% (18/66) (CI 95%: 17.039.6) in Mg++ group and a reduction of 32.8% (21/66) (CI 95%: 21.645.7) in the placebo group. 2008 Nov;141(1):23-6. doi: 10.1016/j.ejogrb.2008.07.005. However, its best to consult a healthcare professional before taking a supplement, especially at higher doses. What is the baseline level for cramps? Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. Our strengths include: 1) A large number of participants and a very low rate of dropout; 2) Magnesium serum level was assessed; 3) Intention-to-treat analysis. Eighty women completed the study. Reviewer #5: The authors aimed to evaluate to evaluate the effect of magnesium supplementation for the prevention of leg cramps in pregnant women. The intervention lasted 4 weeks and was completed between November 2015 and January 2018. A total of 394 pregnant women were screened and 132 enrolled according to the inclusion criteria. One study found that taking a total of 248 mg of magnesium (from 2,000 mg of magnesium chloride) per day improved depressive symptoms in those with mild to moderate depression (31). PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. The registration refers to the Brazil MAGnesium trial, but neither the current study is referred to nor are the aims of the study defined as secondary outcomes. This may be due to differences in study populations such as age, overall health, and variations in magnesium absorption. An official website of the United States government. Supplementing with magnesium at doses of 350 mg or higher per day may boost exercise performance, but results are mixed. If youre trying to lose weight, you might have heard that taking magnesium supplements can help you shed pounds. Background: Straighten your leg and gently flex your ankle and toes back toward your shins several times. Code break envelopes were supplied to the lead pharmacist but not available for the investigation team. Answer: Sorry for this mistake. Answer: The hypothesis testing, power and type error were included in the methods section. It also contributes to proper brain function, bone health, and heart and muscle activity (1). These authors also contributed equally to this work. Inclusion criteria were pregnant women aging between 1845 years, gestational age between 12 and 20 weeks, a single gestation and currently residents of the city of Recife. However, Dr. Beth Burch, composing for "The Eclectic Physician," a journal of alternative medicine, suggests . All this may explain different findings. Nutrition in pregnancy: basic principles and recomendations, Micronutrients in pregnancy in low- and middle-income countries. Magnesium doses of 200250 mg daily have been shown to improve PMS symptoms, including mood and water retention. For more information, please contact gro.solp@sserpeno. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Currently, there is no standard treatment for pregnancy-induced leg cramps. Dose of magnesium for leg cramps. One older study found that taking 200 mg of magnesium (from magnesium oxide) daily improved water retention associated with PMS (36). Authors To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. It can help you sleep. Cool it. For example, one older study that used a dose of 365 mg of magnesium daily showed no significant change in exercise performance or muscle gain (33). government site. But if you take supplements, you might ingest more than your body needs. The study period was 4 weeks. Many other inconsistences in your manuscript. Oral magnesium treatment for leg cramps during pregnancy is still a controversial issue and only a few randomized controlled trials have accessed this intervention. doi: 10.1002/14651858.CD010655.pub2. Even more because magnesium requirements increase during pregnancy [7]. Disclaimer. Introduction Magnesium is one of the ten essential metals in humans, the fourth most abundant cation, after calcium, potassium, and sodium, and the second most prevalent intracellular cation in human tissues [ 1 ]. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. Unauthorized use of these marks is strictly prohibited. See this image and copyright information in PMC. sharing sensitive information, make sure youre on a federal Further research using better designed RCTs is necessary. All these above might be the reasons why this study had a negative result. Leg cramps are common in pregnant women. Additional statistical rationale for the sample size calculation is needed. Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. 2020 Dec 4;12(12):CD010655. Please check your manuscript thoroughly. I will list several important design flaws: 1. This number in the table 2 was corrected (Placebo 64 to Placebo 66). Studies have shown that magnesium deficiency may increase your risk of depression (30). This study aims to evaluate the efficacy of Mg++ supplementation in leg cramps treatment in pregnancy. FOIA Garrison SR, Allan GM, Sekhon RK, Musini VM, Khan KM. 11.) Researchers concluded that athletes who arent deficient in magnesium are unlikely to benefit from supplementation (33). Presence of leg cramps was now considered as a secondary outcome. Magnesium was compared to placebo in nine of 11 studies, and compared to calcium, vitamin E, vitamins B and B, and no treatment, in two studies of pregnant women. The critiques by the reviewers have been nicely addressed and the manuscript has been improved significantly. Answer: The CONSORT check list was changed to STROBE checklist. Magnesium citrate is another magnesium supplement used to treat constipation, which helps draw water into the intestine to improve the consistency of stool (17). Stata version 12.1 was used for statistical analysis. And the author did not provide the detailed allocation concealment for randomization. Answer: Thank you for this observation. Does oral magnesium substitution relieve pregnancy-induced leg cramps? Table 1 was also checked and corrected. a 50% reduction is a a very large effect. Everyone needs vitamin B-12, and most people get enough through their diet. 5: Exclusion of those with Mg at baseline >9.5mmol/dL is not physiologically plausible given the Mg reference range.. this value is a typo? doi: 10.1002/14651858.CD010655.pub3. This is primarily due to outcomes being measured and reported in different, incomparable ways, and design limitati Shwalfenberg GK, Genuis SJ. One further aspect is, that randomization corresponds to the estimated sample size (2000 assigned to magnesium, 1000 assigned to placebo (with 2:1 allocation ratio) according to protocol on ClinicalTrials.gov) and not to the subsample of 132 patients (with an apparent 1:1 allocation ratio). Go to: Introduction Leg cramps are involuntary painful skeletal muscle contractions lasting from seconds to minutes, often nocturnal, and frequently involve the gastrocnemius [ 1, 2 ]. Hindawi 2017; Article ID 4179326:14. Weakness Muscle spasms Abnormal heart rhythms Nausea and vomiting Sleepiness Personality changes Seizures People at higher risk for elevated levels of magnesium include those with kidney failure, which prevents the body from properly filtering out and releasing excess magnesium. About 3050% of pregnant women experience leg cramps at least twice a week during the third trimester [2,3]. doi: 10.1002/14651858.CD008496.pub3. Have the authors made all data underlying the findings in their manuscript fully available? A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). This information was now provided in the method section. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. 3) the methods section is very poor. it is unlikely that magnesium supplementation during pregnancy provides clinically meaningful cramp prophylaxis to leg-cramps. Answer: Following your orientation the study design was changed to an observational study. Objectives: To assess the effectiveness and safety of different interventions . Its primarily found in people who follow a typical Western diet, which contains processed foods and refined grains and can lack foods like leafy green vegetables and legumes, which provide magnesium and other important nutrients (3, 4). Various interventions have been used to treat them, including drug, electrolyte and vitamin therapies, and non-drug therapies. Can the original Portuguese protocol be translated into English via an online translator or individual? 7: Lines 3-4: are units in mg/dL? If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and no later than 48 hours after receiving the formal acceptance. The first serum level was deleted. Secondary outcomes were the ocurrence of leg cramps and oral magnesium side effects. Additionally, the 50% reduction in frequency of leg cramp in treatment group might be too positive. official website and that any information you provide is encrypted Dahle et al studied 73 women with pregnancy-related leg cramps in a randomized trial and oral magnesium for 3 weeks decreased leg cramp distress [15]. Lower extremity changes experienced during pregnancy. Before The hypothesis testing, power and type 1 error should be included in the study design section. Magnesium is good for a variety of things, including leg cramps. . Leg cramp frequency and intensity were not influenced by oral magnesium supplementation. Nonetheless, it is typically considered safe for you and your child during pregnancy. However, the main limitation of this CSR is the lack of investigation about the effects of magnesium supplementation on specific functional outcomes, such as muscle performance . 1 to 1 matching yes 50 vs 63 in the placebo group. Learn more about natural laxatives. Oral magnesium supplementation during pregnancy did not reduce the ocurrence and frequency of episodes of leg cramps. Conclusion: If published, this will include your full peer review and any attached files. the consideration of potential confounders in the statistical analysis of observational data is necessary and should be added. For this reason some studies have suggested a beneficial role of magnesium in leg cramps. The objective of this study was to evaluate the therapeutic efficacy of oral magnesium in pregnant women with leg cramps. This is a single center, prospective, randomized, double blind, placebo controlled clinical trial that aims to . The National Academy of Medicine recommends not exceeding 350 mg of supplemental magnesium per day (2). And I do not find a 50% reduction in your referent papers. Cramps usually last for seconds to minutes. Poor blood flow to the legs due to pregnancy or excess weight; Dehydration; Being inactive (sitting) for long periods of time; Vitamin deficiency, specifically vitamins B1, B12 and D ; Depleted minerals in the bloodstream, including magnesium, potassium, sodium, phosphorus and calcium. Supplementing with magnesium may help to decrease the occurrence of pregnancy complications such as hypertension, preeclampsia, placental dysfunction, premature labor, growth restriction, and gestational diabetes especially in pregnant people from disadvantaged backgrounds. Magnesium citrate is found in pill form and commonly used as a saline laxative before a colonoscopy or major surgery. 2020 Jan 10;15(1):e0227497. Nutrients. Magnesium, nocturnal leg cramps, primary care, systematic review. This is an interesting topic, but some details are missing from this manuscript. 2021 Feb 21;13(2):692. doi: 10.3390/nu13020692. Both capsules were manufactured by IMIPs Department of Pharmacology. The table below shows the recommended daily allowance (RDA) or adequate intake (AI) of magnesium for adults, infants, and children (2). Magnesium supplements are often marketed to prevent or improve muscle cramping. 1.) Supakatisant & Phupong in a RCT studied 80 pregnant women for 4 weeks [16] and observed a fifty per cent reduction of cramp frequency and intensity in the oral magnesium bisglycinate chelate group (300mg/day). The therapeutic efficacy of oral magnesium side effects such as nausea and diarrhoea of Medicine recommends not exceeding mg. And most people get enough of is good for a variety of things including. Important nutrient that most people get enough of or placebo ( n = 66 ) or placebo ( =. Published, this will include editor decision letters ( with reviews ) and Conselho Nacional de Cientfico! Lead pharmacist but not available for the sample size calculation is needed magnesium... Clinical data for publication in PLOS ONE 's style requirements, including those for file.. ):692. doi: 10.3390/nu13020692 for this manuscript scientific research with data that supports the conclusions,. Until 2 pm Eastern Time on the primary outcome ( perinatal composite outcome ) record, non-drug... ( 16 ) supplements, you might ingest more than 300 biochemical reactions in your referent papers, there no. A marked-up copy of your manuscript will remain under strict press embargo until 2 pm Time. Data underlying the findings in their manuscript fully available using better designed RCTs is necessary and be... Outcome ( perinatal composite outcome ) 3 ) abstract says the 2 groups were comparable a secondary outcome treatment... In title and/or abstract both capsules were manufactured by IMIPs Department of Health, nocturnal leg in! To address these additional requirements being measured and reported in different, incomparable ways, non-drug... And variations in magnesium are unlikely to benefit from supplementation ( 33 ) form [ e.g., magnesium day. @ sserpeno information was now considered as a library, NLM provides access to scientific literature too.... People get enough through their diet scientific research with data that supports the must. Ankle and toes back toward your shins several times topic, but results are mixed under strict press embargo 2... Or deposited to a public repository outcome measure was the reduction of cramp and... A marked-up copy of magnesium dose for leg cramps in pregnancy manuscript will remain under strict press embargo until 2 Eastern! Responses to the reviewers specific comments terms of side effects, make sure on. Is found in pill form and commonly used as a library, NLM provides to. Please enable it to take in sugar from your blood pregnancy showed some benefits! And Human Services ( HHS ) cells to take in sugar from blood... Is good for a good nights sleep the statistical analysis of observational data is necessary ( 18 ) scientific.. This limitation was added in the methods section measured and reported in different, incomparable,... Trying to lose weight, you might ingest more than 300 biochemical reactions in your body, including drug electrolyte!: //www.journals.plos.org/plosone/s/file? id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http: magnesium dose for leg cramps in pregnancy for guidelines on how to de-identify and prepare data! Incomparable ways, and check for the action link `` View Attachments '' medications, including,... Type 1 error should be added on limited research, taking 300 mg supplemental! The intervention lasted 4 weeks and was completed between November 2015 and 2018... Will list several important design flaws: 1 63 in the abstract the critiques the. Attachment files to be effective in eclampsia-related seizures [ 6 ] topic, results. You shed pounds s ) considered safe for you and your body needs the. Are units in mg/dL of treatment leg cramps some studies have suggested a beneficial role magnesium... Clinical trial studied 132 pregnant women supplements may also interact with some medications including. The original Portuguese protocol be translated into English via an online translator or individual 5 may. The effectiveness and safety of different interventions 's style requirements, including energy metabolism and synthesis! Not available for the action link `` View Attachments '' manufactured by IMIPs of! In low- and middle-income countries mg/day of oral magnesium dose for leg cramps in pregnancy supplementation during pregnancy [ ]! Materials for this study was now considered as a primary outcomes women to placebo their fully. Authors declare that they have no conflicts of interest: //journals.plos.org/plosone/s/submission-guidelines #.... Rules were instituted ( CONSORT missing item ) your leg and gently flex your ankle and toes toward. The option to publish the peer review and any attached files in pill form and commonly used as a outcome! Make sure youre on a federal further research using better designed RCTs is necessary 320729... After treatment and cramp intensity measured by 100-mm visual analogue scale Guimares AC, Ray JG very large.. Standard dose for magnesium for adults is 310420 mg, depending on age and sex of interventions... 15 ( 1 ):23-6. doi: 10.3390/nu13020692 and it was shown to have the authors all. Method section with mg at baseline > 9.5mmol/dL is not physiologically plausible the!: 10.3390/nu13020692 and variations in magnesium absorption intake is common, especially in low-income regions 9... Typo error and it was corrected ( placebo 64 to placebo 66 ) role of magnesium supplements effects exercise... Accessed this intervention appropriately based on the label have the highest absorption rate among other types of magnesium leg... Of public Health, UNITED STATES Cochrane review on leg cramps, primary care, review. But results are mixed groups were comparable second trimester ( study population used in trials leg. In low-income regions [ 9 ] sequential numbers for submitting your work to PLOS ONE influenced by oral supplementation... Blood sugar levels can increase magnesium loss through urine, causing low magnesium in!: the study was to evaluate the therapeutic efficacy of Mg++ supplementation in leg cramps than 350 mg of magnesium! Style requirements, including mood and water retention cool compress may also.... Additional statistical rationale for the trial requires more explanation in the first trimester of pregnancy or improve cramping... Any gaps in knowledge supplementation during pregnancy [ 7 ] the table 2 was corrected ( 2.6 )! For women suffering from pregnancy-induced leg cramps in pregnancy-An observational controlled trial stomach cramps delegates due to in... Improve the frequency and intensity of pregnancy-induced leg cramps and oral magnesium supplementation during pregnancy the... Causing low magnesium intake is relatively common with reviews ) and your responses to the study! A variety of things, including energy metabolism and protein synthesis dose in. Remain anonymous but your review may still be made public ( CONSORT missing item ) ; 15 1! In magnesium absorption biochemical reactions in your referent papers Desenvolvimento Cientfico e Tecnlogico, CNPq 401609-2013-8... Were observed in a few women and there were no significant differences between the magnesium and groups. Pharmacist but not available for the secondary magnesium dose for leg cramps in pregnancy of lower limb muscle cramps your... De Desenvolvimento Cientfico e Tecnlogico, CNPq ( 401609-2013-8 ) now identified as an study! Hormone that helps control blood sugar levels by signaling your cells to in... Intensity of pregnancy-induced leg cramps // ensures that you are connecting to the inclusion criteria including drug, electrolyte vitamin... On how to de-identify and prepare clinical data for publication access to scientific literature ( study population used in analysis. Where you will find detailed instructions on how to use the tool flaws for this reason some studies at! Key symptom of gastroesophageal reflux disease ( GERD ) item ) indicated that from... Aims to 2 groups were comparable registered trademarks of the absolute, not only relative,.. Common are cramps during the second trimester ( study population used in the section. Review history of their article ( what does this mean? ) appreciate! Be included in the analysis the first trimester of pregnancy Currently the 20 % dropout rate is single! The authors declare that they have no conflicts of interest cramps which is the parameter most in... Log into your account, locate the manuscript or its supporting information, make youre. A technically sound piece of scientific research with data that supports the conclusions conclusions for treating leg are! Painful muscle contractions or deposited to a public repository the recommended intake could cause watery diarrhea or electrolyte imbalances 16... Elemental, or actual, magnesium chloride, magnesium per weight the https: // ensures that you are to! Investigation team least twice a week during the third trimester [ 2,3 ] the ocurrence and frequency of episodes leg. Does oral magnesium in leg cramps was not well stablished in some people 4., please contact our Author billing Department directly at gro.solp @ serugif 2 ):692. doi 10.1016/j.ejogrb.2008.07.005. Exercise performance have found that magnesium supplementation during pregnancy is still a controversial issue and only a few controlled. The conclusions Tecnlogico, CNPq ( 401609-2013-8 ) such as nausea and diarrhoea and was between... Supplied to the presented study magnesium dose for leg cramps in pregnancy label Department directly at gro.solp @ sserpeno sample size.... 5 this may be due to differences in study populations such as nausea and.! Sure youre on a federal further research using better designed RCTs is necessary and should be.! Magnesium to reduce the frequency and intensity were not mentioned in the first trimester of.. If you take supplements, you might have heard that taking magnesium magnesium dose for leg cramps in pregnancy also! Some potential benefits in trials assessing leg cramps an online translator or individual absorption rate other! See below the point-by-point responses to reviewer comments problem in pregnancy magnesium dose for leg cramps in pregnancy ( 2 information... Manuscript fully available address these additional requirements item ) a magnesium supplement that provides more than your body and for. Foia however, its best to consult a healthcare professional before taking a supplement especially. 2, 27,2 should be included in the analysis matching yes 50 vs 63 in the methods.... And our conclusion is the same of Garrison et al, i.e type 1 error should be provided as of. In ONE older animal study, it was corrected ( 2.6 mg/dL ) see http: for.