LAUSR

Abstract Background: The aim of this randomized clinical trial (RCT) was to evaluate the effect of vitamin D supplementation in obese, insulin-resistant (IR) and vitamin D-deficient polycystic ovary syndrome (PCOS) women on metabolic abnormalities in comparison to the effect of metformin or combined metformin plus vitamin D therapy. Material and methods: Thirty-nine PCOS women who fulfilled the inclusion criteria were randomized into three groups and treated with alfacalcidiol, combined alfacalcidiol and metformin therapy and metformin for 6 months. Body weight, body mass index (BMI), waist circumference, total body fat and fat distribution were measured before and after 6 months of treatment. Plasma fasting glucose, insulin, homeostasis model assessment-insulin resistance (HOMA-IR) and lipid profiles were measured at the same time. Results: There was a significant decrease in body weight, BMI, waist circumference, total body fat and serum glucose levels in the metformin group (p<0.05), whereas PCOS women treated with alfacalcidiol did not significantly change their anthropometric and metabolic parameters. A significant decrease in waist circumference (p<0.05) in the group treated with metformin and alfacalcidiol was detected without other significant metabolic changes (all p>0.05). There were no significant changes in metabolic parameters (p>0.05) after vitamin D therapy except for a slight but non-significant trend towards higher high-density lipoprotein (HDL) cholesterol levels (p=0.087). Conclusion: We conclude that vitamin D supplementation has no significant effect on anthropometric and metabolic parameters in PCOS women. Metformin has been still the most effective modality for the treatment of metabolic changes in PCOS.