Effects of Melatonin and/or Magnesium Supplementation on Biomarkers of Inflammation and Oxidative Stress in Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial.

Magnesium and melatonin are known to exert multiple beneficial effects including anti-inflammatory and antioxidant actions. This study was designed to determine the effects of magnesium and/or melatonin supplementation on metabolic profiles in women with polycystic ovary syndrome (PCOS). This randomized double-blind, placebo-controlled trial was conducted among 84 subjects with PCOS aged 18-40 years old. Patients were randomly assigned based on the random block procedure to take magnesium, melatonin, magnesium plus melatonin, or placebo for 8 weeks. Fasting blood samples were taken at baseline and after the intervention to quantify related variables. After the 8-week intervention, an insignificant marginal difference was seen in waist circumference (WC) between groups (P = 0.085). Magnesium-melatonin co-supplementation resulted in more reductions in hirsutism compared with other groups (P < 0.001). Serum levels of tumor necrosis factor-α (TNF-α) declined significantly in the melatonin and co-supplementation groups compared to baseline (P < 0.05). Also, magnesium plus melatonin was associated with a more increase in total antioxidant capacity (TAC) levels, as compared to the other treatment groups (P = 0.001). Overall, we found a favorable effect of co-supplementation of magnesium and melatonin for 8 weeks in women with PCOS on hirsutism, serum TNF-α, and TAC levels. Furthermore, melatonin independently contributed to decreased serum values of TNF-α.Clinical trial registration number http://www.irct.ir : IRCT20191130045556N1, January 2020.