Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
Recruiting · NCT04355572 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboVitamin D 4000IU daily
What this trial is about
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
Who can take part
Age range
13 Years to 21 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Yale New Haven Children's Hospital - New Haven, Connecticut, United States