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Effect of Vitamin D and Letrozole on Ovulation in Polycystic Ovary Syndrome
Published: BMJ Open, April 29, 2024
Low vitamin D levels are common in women with polycystic ovary syndrome (PCOS). This study aims to evaluate the impact of vitamin D supplementation on ovulation rates with letrozole and other reproductive, endocrine, and metabolic outcomes in women with PCOS over 1 year.
Study Design and Approach
This is a multicenter, randomized, double-blind, controlled clinical trial involving 220 anovulatory women diagnosed with PCOS. Participants will be randomly assigned to receive either vitamin D supplementation or a placebo. The vitamin D group will receive oral Vitamin D3 at specified intervals. Those who remain anovulatory after 6 months will undergo a 6-month course of letrozole for ovulation induction. Statistical analyses will include intention-to-treat and per protocol analyses.
Ethics and Dissemination
Ethics approval was obtained from the Institutional Review Board, and all participants will provide written informed consent. The study results will be shared at scientific conferences and published in peer-reviewed journals.
Clinical Trial Registration
Trial Registration Number: NCT04650880
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