A Summary of a Magnesium Clinical Study by Barna et al. (2021)

Reviewed by Tamberlyn Blinsink, ND, MPH | Research & Development

Overview

The following summary reviews clinical research examining oral magnesium supplementation in the context of nocturnal leg cramps (NLC) in an adult population aged 45 and older. Magnesium supplements are commonly used for the prophylaxis and treatment of NLC; however, the authors noted that evidence supporting their effectiveness has remained limited. The study evaluated a specific magnesium form — magnesium oxide monohydrate (MOMH) — for which increased cellular absorption had been previously demonstrated in an ex-vivo setting. The aim of the study was to determine whether a 60-day administration period would produce clinically meaningful effects.

Summary

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

Published in: Nutrition Journal

Study Design: Randomized, double-blind, placebo-controlled, multicenter trial

Participants: 175 adults (aged ≥45 years) with confirmed nocturnal leg cramps, recruited from hospitals and outpatient clinics across 7 sites in Ukraine

Dose: 226 mg once daily at bedtime for 60 days

Outcome Measures: Number of NLC episodes per week (primary); NLC episode duration, NLC-associated pain (Visual Analogue Scale, 0–10), sleep quality (Visual Analogue Scale, 0–5), and quality of life (SF-36) (secondary)

What Was Studied: Researchers set out to assess the efficacy and safety of a magnesium dietary supplement — MOMH — in treating nocturnal leg cramps in adults aged 45 and older. The study was structured as a prospective, multicenter, randomized, double-blind, placebo-controlled trial conducted over a 60-day treatment period. The study was preceded by a 2-week screening period during which subjects were monitored for NLC episodes. Eligible subjects were randomly allocated in a 1:1 ratio to receive either MOMH or placebo once daily at bedtime. Clinical assessments were performed at baseline, Day 30, and Day 60, with subjects tracking NLC episodes, pain, and sleep quality via daily diaries. Statistical comparisons between groups were conducted using ANOVA and the Fisher's Exact Test, with a significance level set at 0.05.

About the Reviewer

Name & Title: Tamberlyn Blinsink, Scientific Researcher at Solaray
Credentials: Naturopathic Doctor, Master of Public Health

Bio: Tamberlyn Blinsink, ND, MPH, a licensed naturopath who earned her Doctorate of Naturopathic Medicine from Bastyr University and her Master of Public Health from Purdue University. In addition to her experience in private practice, Dr. Blinsink, ND, MPH is a researcher in the natural products industry. She believes in giving back and has served as a lecturer at continuing education conferences and as a board member at Naturopaths Without Borders and NC Association of Naturopathic Physicians.

References

Barna O, Lohoida P, Holovchenko Y, Bazylevych A, Velychko V, Hovbakh I, Bula L, Shechter M. 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;20(1):90. https://pubmed.ncbi.nlm.nih.gov/34719399/

Back to blog

Frequently Asked Questions

What makes a study “double-blind”?

In double-blind studies, participants and researchers are
both unaware of which participants are in the group taking the active
investigational product and which are part of a control group.

What makes a study “placebo-controlled”?

When studies are placebo-controlled one group takes an active
investigational product and the other group takes an inactive product that has
the same general appearances as the active treatment.

What is a placebo?

Placebos are inactive treatments. Researchers include placebos that have the same general characteristics as an active treatment.

They try to make them indistinguishable from the active treatment regarding
qualities like appearance, taste, and smell.

Why is statistical significance important?

Quality scientific studies look for more than just a numerical difference between treated groups and control groups. These studies also check mathematically for the possibility that any difference between groups might
happen by chance. A difference that is statistically significant is one where the change is not likely to be due to a chance fluctuation within a normal variance.

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.