The effects of calcitriol on improvement of insulin resistance, ovulation and comparison with metformin therapy in PCOS patients: a randomized placebo- controlled clinical trial

Background: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in females of reproductive age. Insulin resistance is a frequent metabolic disturbance in PCOS. Vitamin D deficiency is a common problem. Accumulating evidence suggests that vitamin D has a role on insulin sensitivity so may contribute to reduction of hyperandrogenemia. Objective: The aim was to determine the effects of vitamin D treatment in metabolic components and ovulation evidence in PCOS. Materials and Methods: Fifty one untreated PCOS patients were randomly divided into three groups and treated with calcitriol, metformin, or placebo. Before and 3 months after treatment, ovulation evidence was assessed by ovarian trans abdominal sonography. Plasma fasting glucose, insulin, homeostasis model assessment insulin resistance (HOMA-IR), 25-hydroxyvitamin D, parathyroid hormone and androgen levels were measured before and after treatment. A 75gr glucose test was performed before and after treatment and two set of results was compared. Results: Three patients did not continue this study. Only 11 patient (22.9%) had sufficient vitamin D levels (>30 ng/ml). Metformin caused a significant decrease in weight (p=0.027), insulin level (p=0.043), and insulin resistance (p=0.048). Systolic blood pressure and PTH significantly improved after calcitriol (p=0.029, p=0.009 respectively). An improvement in ovulation was detected after calcitriol and seven patients, without evidence of ovulation before treatment, illustrated ovulation after 3 months. Difference with calcitriol in ovulation was significant versus other two methods (p=0.02). Conclusion: Calcitriol treatment in PCOS may be prior to metformin in ovulation induction.