RecruitingNot Applicable

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

United States60 participantsStarted 2026-05

Plain-language 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

Who can participate

Age range13 Years – 21 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng/mL. Exclusion Criteria: * Other causes for hyperandrogenism, * Chronic renal diseases, * Acquired or inherited calcium and vitamin D metabolic disorders.

What they're measuring

Change in oligomenorrhea

Timeframe: 6 months

Changes Vitamin D (25-hydroxyvitamin D) level

Timeframe: at enrollment, at 3 months after randomization and 6 months after randomization

Trial details

NCT IDNCT04355572

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Alla Vash-Margita, MD

203-785-4010 alla.vash-margita@yale.edu

View on ClinicalTrials.gov More Polycystic Ovarian Syndrome in Adolescent Females trials