A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps

Abstract Background Magnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC). However, there is little evidence in support of their effectiveness. The main impediment stems from the lack of assessments of cellular absorption. In the current study, we tested t...

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Autores principales:	Olha Barna, Pavlo Lohoida, Yurii Holovchenko, Andrii Bazylevych, Valentyna Velychko, Iryna Hovbakh, Larysa Bula, Michael Shechter
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Nocturnal leg cramps NLC Magnesium Food supplement Nutrition. Foods and food supply TX341-641 Nutritional diseases. Deficiency diseases RC620-627
Acceso en línea:	https://doaj.org/article/2743fe6795fa47c88d707d7b912725a0
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spelling	oai:doaj.org-article:2743fe6795fa47c88d707d7b912725a02021-11-07T12:14:02ZA randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps10.1186/s12937-021-00747-91475-2891https://doaj.org/article/2743fe6795fa47c88d707d7b912725a02021-10-01T00:00:00Zhttps://doi.org/10.1186/s12937-021-00747-9https://doaj.org/toc/1475-2891Abstract Background Magnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC). However, there is little evidence in support of their effectiveness. The main impediment stems from the lack of assessments of cellular absorption. In the current study, we tested the efficacy and safety of a magnesium supplement – magnesium oxide monohydrate (MOMH), for which increased cellular absorption rates were demonstrated in an ex-vivo setting. Methods A randomized, double-blind, placebo-controlled multicenter study was conducted in hospitals and outpatient clinics in Ukraine, from February to August 2018. Eligible subjects received a capsule with MOMH 226 mg or placebo, once daily, at bedtime, for a 60-day period. The assessed parameters included frequency and duration of NLC episodes, quality of sleep, NLC-induced pain and quality of life sub-scores. The Fisher’s Exact Test for comparison of groups by categorical variables was used. The Student’s test or Mann-Whitney test were used for between-group comparison at different timepoints. ANCOVA followed by contrast analysis was used for comparison of groups at the end of the study. Results 175 (81%) out of 216 initially screened subjects completed the study. The number of NLC episodes has significantly decreased by the end of the study period as compared to baseline in both groups (p < 0.001 for both). There was a significant between-group difference in the magnitude of reduction in NLC episodes (p = 0.01), indicating a higher decrease in the MOMH group as compared to the placebo group (− 3.4 vs − 2.6, respectively). In addition, MOMH treatment resulted in a greater reduction in NLC duration (p < 0.007) and greater improvement in sleep quality (p < 0.001) as compared to placebo. Conclusions MOMH was shown to be effective in the treatment of NLC as well as safe and well-tolerated. Trial registration NCT03807219 , retrospectively registered on January 16, 2019.Olha BarnaPavlo LohoidaYurii HolovchenkoAndrii BazylevychValentyna VelychkoIryna HovbakhLarysa BulaMichael ShechterBMCarticleNocturnal leg crampsNLCMagnesiumFood supplementNutrition. Foods and food supplyTX341-641Nutritional diseases. Deficiency diseasesRC620-627ENNutrition Journal, Vol 20, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Nocturnal leg cramps NLC Magnesium Food supplement Nutrition. Foods and food supply TX341-641 Nutritional diseases. Deficiency diseases RC620-627
spellingShingle	Nocturnal leg cramps NLC Magnesium Food supplement Nutrition. Foods and food supply TX341-641 Nutritional diseases. Deficiency diseases RC620-627 Olha Barna Pavlo Lohoida Yurii Holovchenko Andrii Bazylevych Valentyna Velychko Iryna Hovbakh Larysa Bula Michael Shechter A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps
description	Abstract Background Magnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC). However, there is little evidence in support of their effectiveness. The main impediment stems from the lack of assessments of cellular absorption. In the current study, we tested the efficacy and safety of a magnesium supplement – magnesium oxide monohydrate (MOMH), for which increased cellular absorption rates were demonstrated in an ex-vivo setting. Methods A randomized, double-blind, placebo-controlled multicenter study was conducted in hospitals and outpatient clinics in Ukraine, from February to August 2018. Eligible subjects received a capsule with MOMH 226 mg or placebo, once daily, at bedtime, for a 60-day period. The assessed parameters included frequency and duration of NLC episodes, quality of sleep, NLC-induced pain and quality of life sub-scores. The Fisher’s Exact Test for comparison of groups by categorical variables was used. The Student’s test or Mann-Whitney test were used for between-group comparison at different timepoints. ANCOVA followed by contrast analysis was used for comparison of groups at the end of the study. Results 175 (81%) out of 216 initially screened subjects completed the study. The number of NLC episodes has significantly decreased by the end of the study period as compared to baseline in both groups (p < 0.001 for both). There was a significant between-group difference in the magnitude of reduction in NLC episodes (p = 0.01), indicating a higher decrease in the MOMH group as compared to the placebo group (− 3.4 vs − 2.6, respectively). In addition, MOMH treatment resulted in a greater reduction in NLC duration (p < 0.007) and greater improvement in sleep quality (p < 0.001) as compared to placebo. Conclusions MOMH was shown to be effective in the treatment of NLC as well as safe and well-tolerated. Trial registration NCT03807219 , retrospectively registered on January 16, 2019.
format	article
author	Olha Barna Pavlo Lohoida Yurii Holovchenko Andrii Bazylevych Valentyna Velychko Iryna Hovbakh Larysa Bula Michael Shechter
author_facet	Olha Barna Pavlo Lohoida Yurii Holovchenko Andrii Bazylevych Valentyna Velychko Iryna Hovbakh Larysa Bula Michael Shechter
author_sort	Olha Barna
title	A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps
title_short	A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps
title_full	A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps
title_fullStr	A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps
title_full_unstemmed	A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps
title_sort	randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps
publisher	BMC
publishDate	2021
url	https://doaj.org/article/2743fe6795fa47c88d707d7b912725a0
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A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps

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