Status:
RECRUITING
Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
Lead Sponsor:
Yale University
Conditions:
Polycystic Ovarian Syndrome in Adolescent Females
Vitamin D Deficiency
Eligibility:
FEMALE
13-21 years
Phase:
NA
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 ...
Detailed Description
Patients referred to the pediatric endocrinology clinic or adolescent gynecology clinic at Yale New Haven Children Hospital with a primary complaint of hirsutism, acne, or amenorrhea and/or oligomenor...
Eligibility Criteria
Inclusion
- \- 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
- Other causes for hyperandrogenism,
- Chronic renal diseases,
- Acquired or inherited calcium and vitamin D metabolic disorders.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04355572
Start Date
November 1 2025
End Date
July 1 2027
Last Update
October 31 2025
Active Locations (1)
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1
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06510