Population studied: 262 subjects. 8-week, Phase IV, randomized, controlled, investigator-blinded, parallel-group trial stratified by sex.
Method: The modified Intention-To-Treat (mITT) population was defined as all subjects with an evaluable DASS-42 stress subscale score at baseline and at least one other time point during the treatment period. The Per Protocol (PP) population was defined as all subjects included in the mITT analysis without any major protocol deviations.
Results: Both magnesium in combination with vitamin B6, and Mg alone reduced stress from baseline to Week 8 by approximately 40% in the overall adult population studied. In people with severe or extremely severe stress with low serum magnesium concentration, the Mg–vitamin B6 combination provided a 24% greater reduction in stress than Mg alone at Week 8. These clinical data support the use of Mg supplementation to reduce stress in stressed adults with low serum magnesium concentrations.
Reference
E. Pouteau, M. Kabir-Ahmadi, L. Noah, A. Mazur, L. Dye, J. Hellhammer, G. Pickering, C. Dubray, Y. Song, PLOS One, 2018, 13. Superiority of magnesium and vitamin B6 over magnesium alone on severe stress in healthy adults with low magnesemia: A randomized, single-blind clinical trial.