Study of Vitamin D Treatment Effects on Symptoms and Hormones in Adolescent Females at Risk for Polycystic Ovarian Syndrome PCOS

What this Trial Is About

Researchers are evaluating vitamin D replacement in adolescent females at risk for Polycystic Ovarian Syndrome PCOS who have low vitamin D levels. This randomized, double-blind, placebo-controlled trial aims to study the clinical, biochemical, and psychological effects of vitamin D supplementation on PCOS symptoms and hormone levels. The study involves participants diagnosed using Rotterdam criteria and vitamin D levels between 6 and 29 ngmL. Participants will be randomly assigned to receive either a daily vitamin D supplement of 4,000 IU or a placebo for 6 months. The study includes repeated lab tests at the start, 3 months, and 6 months to measure vitamin D, hormone levels, lipid profile, glucose, insulin, and depression symptoms using the Beck Depression Inventory-II. Those with vitamin D levels of 5 ngmL or less will receive standard treatment and will not be randomized. During the study, participants will be closely monitored through physical exams, hormone and vitamin tests, and psychological assessments. After the 6-month trial, participants will be unblinded and those still deficient in vitamin D will be offered treatment. The main outcomes measured include changes in menstrual irregularities and vitamin D levels, with secondary outcomes covering various hormone levels and symptoms like acne and hirsutism. The study is expected to end in December 2027.

Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)