Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 13
Maximum Age: 21
Healthy Volunteers: f
View:
• \- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng/mL.
Locations
United States
Connecticut
Yale New Haven Children's Hospital
RECRUITING
New Haven
Contact Information
Primary
Alla Vash-Margita, MD
alla.vash-margita@yale.edu
203-785-4010
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 60
Treatments
Experimental: Vitamin D Supplement
Patients will take vitamin D tablet with 4,000IU daily for 6 months.
Placebo_comparator: Placebo
Patients will take placebo for 6 months
Related Therapeutic Areas
Sponsors
Leads: Yale University