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NCT04355572
Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
Conditions: Polycystic Ovarian Syndrome in Adolescent Females, Vitamin D Deficiency
Sex: Female
Ages: 13 Years – 21 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Yale University
Location: Yale New Haven Children's Hospital New Haven Connecticut
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.
Source: ClinicalTrials.gov (NCT04355572). StuddyBuddy aggregates publicly available trial information.
