NCT04355572 Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
| NCT ID | NCT04355572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Polycystic Ovarian Syndrome in Adolescent Females |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-05 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Alla Vash-Margita, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT04355572 clinical trial?
This trial is open to female participants only, aged 13 Years or older, up to 21 Years, studying Polycystic Ovarian Syndrome in Adolescent Females. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04355572 currently recruiting?
Yes, NCT04355572 is actively recruiting participants. Contact the research team at alla.vash-margita@yale.edu for enrollment information.
Where is the NCT04355572 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT04355572 clinical trial?
NCT04355572 is sponsored by Yale University. The principal investigator is Alla Vash-Margita, MD at Yale University. The trial plans to enroll 60 participants.