Vitamin D supplements for teenage girls with low vitamin D and PCOS
Tests vitamin D against placebo in teenage girls with PCOS and low vitamin D.
Key facts
- Who runs it
- Yale University
- Where
- New Haven, United StatesSee the site
- Trial code
- Registry title
- Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- Sept 2026
- Expected to end
- 31 Aug 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Vitamin D 4000IU daily
- Placebo
- Record updated
- 20 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for teenage girls and young women with PCOS (polycystic ovarian syndrome) and low vitamin D. They will take vitamin D or a placebo (dummy tablet) for 6 months.
- Age
- 13 to 21 years
- Sex
- Females only
- Disease stage
- PCOS by the modified Rotterdam criteria. Periods must have already started.
- Biomarker or test result
- Blood vitamin D level between 6-29 ng/mL
Main reasons for not taking part
- Other causes of high male hormone levels (hyperandrogenism)
- Long-term kidney disease
- Inherited or acquired disorders of calcium or vitamin D handling in the body
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng/mL
Who cannot take part
- Chronic renal diseases,
- Acquired or inherited calcium and vitamin D metabolic disorders
- Other causes for hyperandrogenism,
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 13 and 21 years old?
Where in United States
- Yale-New Haven Children's HospitalNew Haven, United StatesContact: Alla Vash-Margita, Principal Investigator, MDTaking people
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- Vitamin D SupplementTreatment being tested
Patients will take vitamin D tablet with 4,000IU daily for 6 months.
Treatment: Vitamin D 4000IU daily
- PlaceboPlacebo, for comparison
Patients will take placebo for 6 months
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
- Plain-language title
- Vitamin D supplements for teenage girls with low vitamin D and PCOSGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT04355572, who can take part
- Record updated
- 20 August 2026