Actively Recruiting
Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
Led by Yale University · Updated on 2026-02-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating vitamin D replacement in adolescent females at risk for Polycystic Ovarian Syndrome (PCOS) who have low vitamin D levels. This randomized, double-blind, placebo-controlled trial aims to study the clinical, biochemical, and psychological effects of vitamin D supplementation on PCOS symptoms and hormone levels. The study involves participants diagnosed using Rotterdam criteria and vitamin D levels between 6 and 29 ng/mL. Participants will be randomly assigned to receive either a daily vitamin D supplement of 4,000 IU or a placebo for 6 months. The study includes repeated lab tests at the start, 3 months, and 6 months to measure vitamin D, hormone levels, lipid profile, glucose, insulin, and depression symptoms using the Beck Depression Inventory-II. Those with vitamin D levels of 5 ng/mL or less will receive standard treatment and will not be randomized. During the study, participants will be closely monitored through physical exams, hormone and vitamin tests, and psychological assessments. After the 6-month trial, participants will be unblinded and those still deficient in vitamin D will be offered treatment. The main outcomes measured include changes in menstrual irregularities and vitamin D levels, with secondary outcomes covering various hormone levels and symptoms like acne and hirsutism. The study is expected to end in December 2027.
CONDITIONS
Brief Title
Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS
- Serum vitamin D level between 6-29 ng/mL
You will not qualify if you...
- Other causes for hyperandrogenism
- Chronic renal diseases
- Acquired or inherited calcium and vitamin D metabolic disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for history, physical exam, pelvic ultrasound, and laboratory evaluations including vitamin D level.
Duration - 6 months
Participants are randomized to receive either vitamin D supplement or placebo daily for 6 months.
3 visits (at enrollment, 3 months, and 6 months) for laboratory testing and depression assessment.
Trial Site Locations
Total: 1 location
1
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
A
Alla Vash-Margita, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here