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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Polycystic Ovarian Syndrome in Adolescent Females, Vitamin D Deficiency

In brief

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

Key facts

Study ID

NCT04355572

Run by

Yale University

People needed

60

Starts

2026-05-01

Expected to finish

2027-12-01

Last updated by the study team

2026-02-23

Who can join

Age: 13 and older, up to 21. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng/mL.

You may not qualify if…

• Other causes for hyperandrogenism,
• Chronic renal diseases,
• Acquired or inherited calcium and vitamin D metabolic disorders.

Where it is running

• Yale New Haven Children's Hospital — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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