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

Olha Barna; Pavlo Lohoida; Yurii Holovchenko; Andrii Bazylevych; Valentyna Velychko; Iryna Hovbakh; Larysa Bula; Michael Shechter

doi:10.1186/s12937-021-00747-9

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

Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9.

Authors

Olha Barna¹, Pavlo Lohoida², Yurii Holovchenko³, Andrii Bazylevych³, Valentyna Velychko⁴, Iryna Hovbakh⁵, Larysa Bula⁶, Michael Shechter^{7

8}

Affiliations

¹ Department of General Practice (Family Medicine), Bogomolets National Medical University, Kyiv, Ukraine.
² Day Hospital Department, "Artem" Clinic, Kiev, Ukraine.
³ Neurology Department, Clinical Hospital No.3, Kyiv, Ukraine.
⁴ Family Medicine Department, Railway Clinical Hospital, Odessa, Ukraine.
⁵ Neurology Department, Clinical Hospital No.9, Kharkiv, Ukraine.
⁶ "Desna" Clinic, Ternopil, Ukraine.
⁷ Leviev Heart Center, Chaim Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel. shechtes@netvision.net.il.
⁸ Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. shechtes@netvision.net.il.

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.

Keywords: Food supplement; Magnesium; NLC; Nocturnal leg cramps.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Double-Blind Method
Humans
Magnesium Oxide*
Muscle Cramp
Quality of Life
Sleep-Wake Transition Disorders* / drug therapy
Treatment Outcome

Substances

Magnesium Oxide

Associated data

ClinicalTrials.gov/NCT03807219