RecruitingNot ApplicableNCT04355572

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


Sponsor

Yale University

Enrollment

60 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a double blind, placebo controlled, randomized trial of study subjects with PCOS and low vitamin D to 2 groups- placebo and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period


Eligibility

Sex: FEMALEMin Age: 13 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether vitamin D supplementation can improve symptoms and metabolic markers in teenage girls with polycystic ovary syndrome (PCOS) who also have low vitamin D levels. PCOS is a hormonal disorder affecting the ovaries and causing irregular periods, excess androgens (male hormones), and sometimes infertility. Vitamin D deficiency is common in PCOS and may worsen hormonal imbalances. Participants receive vitamin D replacement and are monitored for changes in hormone levels, menstrual regularity, and psychological wellbeing. The study addresses both the physical and mental health burden of PCOS in adolescence. You may be eligible if: - You are a postmenarchal female aged 13-21 - You have been diagnosed with PCOS based on modified Rotterdam criteria - Your vitamin D level is between 6-29 ng/mL (deficient range) You may NOT be eligible if: - Your high androgen levels are caused by something other than PCOS (e.g., adrenal tumor) - You have chronic kidney disease - You have a calcium or vitamin D metabolism disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin D 4000IU daily

Randomized to receive vitamin D 4000IU daily

DRUGPlacebo

Randomized to placebo daily


Locations(1)

Yale New Haven Children's Hospital

New Haven, Connecticut, United States

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NCT04355572


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