Vitamin D replacement for adolescent females with PCOS and low vitamin D
Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
NA · Yale University · NCT04355572
This study will try daily vitamin D (4,000 IU) versus placebo in adolescent females ages 13–21 who have PCOS and low vitamin D to see if it improves hormone and metabolic blood tests over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 21 Years |
| Sex | Female |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04355572 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled trial at Yale New Haven Children's Hospital enrolling postmenarchal females (13–21) who meet modified Rotterdam criteria for PCOS and have serum vitamin D 6–29 ng/mL. Participants are randomized to 4,000 IU vitamin D daily or matching placebo and followed for six months with lab testing at baseline, 3 months, and 6 months. Key measurements include AMH, vitamin D, lipid profile, glucose and insulin, androgen testing, and female hormone testing while participants and investigators remain blinded. Patients with severe deficiency (≤5 ng/mL) or other exclusionary conditions are managed clinically rather than randomized.
Who should consider this trial
Good fit: Postmenarchal adolescent females aged 13–21 who meet modified Rotterdam criteria for PCOS and have a serum vitamin D level between 6 and 29 ng/mL, without other causes of hyperandrogenism or calcium/vitamin D metabolic disorders.
Not a fit: Patients with very low vitamin D (≤5 ng/mL), other causes of hyperandrogenism, chronic renal disease, or known calcium/vitamin D metabolic disorders are excluded and would not be expected to benefit from this randomized comparison.
Why it matters
Potential benefit: If successful, vitamin D replacement could improve ovarian hormone markers, menstrual symptoms, and metabolic risk factors in adolescents with PCOS.
How similar studies have performed: Small randomized and observational studies have reported mixed effects of vitamin D on insulin resistance and androgen levels in PCOS, so the approach is plausible but not definitively proven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- Yale New Haven Children's Hospital — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Alla Vash-Margita, MD — Yale University
- Study coordinator: Alla Vash-Margita, MD
- Email: alla.vash-margita@yale.edu
- Phone: 203-785-4010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Polycystic Ovarian Syndrome in Adolescent Females, Vitamin D Deficiency, Anti-Mullerian Hormone