Evaluation of Magnesium, Vitamin D, Calcium, and Metformin Supplements on Cardiometabolic Variables in Infertile Women Diagnosed with Polycystic Ovary Syndrome (PCOS): A Randomized, Controlled, Clinical Trial

Abstract

Background Polycystic ovary syndrome (PCOS) is known as an important etiology of ovulation failure which probably is related to resistance to insulin and other possible related metabolic states. The current study aimed to investigate the effect of supplements such as calcium, vitamin D, and magnesium on cardiometabolic risk factors of infertile PCOS patients. Methods This randomized trial was registrered at Iranian Registry of Clinical Trial (reference code: IRCT2013110615307N1). First, bio-demographic data were gathered and complete physical examinations were performed, for all cases. After meeting the inclusion and exclusion criteria, 106 individuals were randomized into the metformin and vitamin D/calcium (37 patients), metformin and magnesium (34 patients), and metformin (35 patients) groups. After 12 weeks, cardiometabolic parameters including blood pressure, fasting blood sugar (FBS), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride (TG), and dehydroepiandrosterone-sulfate (DHEA-S) were compared among the mentioned groups. In order to compare treatment groups per protocol analysis was performed. All data were analyzed by SPSS and any p-value less than 0.05 was considered statistically significant. Results The results showed no significant difference in age, infertility duration, frequency of metabolic syndrome, and the cause and duration of infertility among the groups. Also, no statistically significant difference was found between patients diagnosed with (N=12, 35%) and without metabolic syndrome. Many of the metabolic factors (body mass index (BMI), blood pressure (BP), FBS, LDL, and cholesterol) were decreased significantly in all groups after the treatments (p<0.001). However, this difference was not statistically significant for HDL, DHEA-S, TG, and testosterone for either of the groups. The mean changes of HDL, testosterone, and LDL were statistically different among the groups (P-values= 0.005, 0.004, and 0.008 for group 1, 2, and 3, respectively). Also, in the metformin and magnesium group, the positive changes of some laboratory parameters were more than the other groups; however, this difference was not statistically significant in most cases. Also, BMI and BP in metformin and magnesium group were more reduced, however, the difference was not statistically significant. Conclusion It seems that treatment with metformin and magnesium may have benefits for patients with PCOS but further clinical trials are necessary.