Vitamin D supplementation in polycystic ovary syndrome: a randomized open label delayed-start design: study protocol

Abstract: Background: Polycystic Ovary Syndrome (PCOS) is a prevalent endocrine disorder affecting reproductive-aged women, characterized by a constellation of symptoms including irregular menstrual cycles, hyperandrogenism, and insulin resistance. Emerging evidence suggests that Vitamin D (VD) deficiency may play a pivotal role in the pathogenesis of PCOS, with low VD levels associated with exacerbation of PCOS-related symptoms and metabolic disturbances. Recently, VD supplementation has garnered increasing attention as a potential therapeutic intervention for PCOS. Methods: In this randomized open label delayed-start design the intervention group will be given a VD injection of 600,000 I.U I/M once with 1-gram calcium supplement daily for 12 weeks, followed by standard PCOS care which will include: i) ‘Glucophage XR 750 mg’ (once for 15 days then twice daily), ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off), with continued calcium supplements for next 12 weeks. Women in the control group will begin with standard PCOS treatment (as above) for 12 weeks, followed by VD and calcium supplementation for the remaining 12 weeks. Blood tests will be done at baseline, week-12 and week-24 between the two groups that will include assessment of: i) hyperandrogenism by ‘ Free Androgen Index’ [Total Testosterone, Steroid Hormone Binding Globulin ii) Insulin resistance (IR) by HOMA-IR (serum Insulin, Fasting Blood Glucose) and iii) oxidative stress by Total Antioxidant Capacity at all three levels for comparative analysis. VD levels after supplementation will be assessed for confirmation of correction and calcium and albumin levels for detection of hypercalcemia.