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

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this randomized controlled trial publication.

Magnesium supplements are widely used for prophylaxis and treatment of nocturnal leg cramps (NLC).

The main impediment stems from the lack of assessments of cellular absorption.

Who Took Part

A randomized, double-blind, placebo-controlled multicenter study was conducted in hospitals and outpatient clinics in Ukraine, from February to August 2018.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

More than one site took part, so the participants came from several places.

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.

What Was Measured

The main impediment stems from the lack of assessments of cellular absorption.

PubMed files the paper under topics including Magnesium Oxide, Muscle Cramp, Quality of Life and Sleep-Wake Transition Disorders.

Author keywords: Food supplement, NLC and Nocturnal leg cramps.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (Nutrition journal), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.