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

NCT04355572

RecruitingNA

Sponsor: Yale University

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

Interventions: Vitamin D 4000IU daily, Placebo

Countries: United States

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 overview

Sex: FEMALE

Age: 13 Years to 21 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

New Haven, Connecticut, United States