A Summary of a Magnesium and Vitamin B6 Clinical Study by Noah et al. (2021)
Reviewed by John Cutts, PhD | Research & Development
Overview
The following summary reviews a post-hoc analysis of a randomized controlled trial examining magnesium supplementation, with and without vitamin B6, on mental health outcomes and quality of life in stressed, otherwise healthy adults with suboptimal magnesium levels. The primary trial from which this analysis was derived examined subjective stress as its primary endpoint; this secondary analysis investigated whether either treatment was also associated with changes in depression, anxiety, and quality of life as measured by validated self-reported instruments.
Summary
Effect of Magnesium and Vitamin B6 Supplementation on Mental Health and Quality of Life in Stressed Healthy Adults: Post-Hoc Analysis of a Randomised Controlled Trial
Published in: Stress and Health
Study Design: Post-hoc analysis of a randomized, investigator-blinded, controlled trial
Participants: 264 adults ages 18–50 years (74% female) with suboptimal serum magnesium levels and moderate to extremely severe subjective stress at screening, as defined by a DASS-42 stress subscale score greater than 18
Dose: Magnesium 300 mg daily, with or without vitamin B6 30 mg daily, for 8 weeks
Outcome Measures: DASS-42 anxiety and depression subscales; Short Form-36 Health Survey (SF-36) eight domain scores, physical summary score, and mental summary score
What Was Studied: This post-hoc analysis examined previously unreported secondary endpoints from a Phase IV trial comparing magnesium supplementation combined with vitamin B6 against magnesium alone in adults with suboptimal magnesemia and elevated stress. The investigators set out to determine whether either treatment was associated with changes in anxiety and depression scores as measured by the DASS-42, and with changes in health-related quality of life as measured by the SF-36, across an 8-week study period. Participants were assessed at baseline, Week 4, and Week 8, and a Mixed Model for Repeated Measures approach was used to estimate within-group changes from baseline and between-group treatment differences at each time point. The analysis was conducted in the intent-to-treat population of 264 participants, 132 per treatment arm.
About the Reviewer
Name & Title: John Cutts, Director of Research at Solaray
Credentials: PhD Pharmacology & Toxicology
Bio: John Cutts, Ph.D. earned his Doctorate of Philosophy in Pharmacology and Toxicology from the University of Alabama at Birmingham and his Bachelors of Science in Chemistry from BYU-Idaho. He has nearly 20 years of experience in the dietary supplement space, with a focus on scientific substantiation, regulatory affairs, and product development. His graduate research centered on the health-related properties of botanical compounds. He currently works in research and development, where he evaluates clinical evidence for dietary supplement ingredients.
References
Noah L, Dye L, Bois De Fer B, Mazur A, Pickering G, Pouteau E. Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post-hoc analysis of a randomised controlled trial. Stress and Health. 2021;37(5):1000–1009. https://pubmed.ncbi.nlm.nih.gov/33864354/