Vitamin D Replacement for Adolescent Females with PCOS
This study is looking at how vitamin D affects adolescent females (ages 13-21) who have Polycystic Ovarian Syndrome (PCOS) and low vitamin D levels. PCOS is a common hormone problem that can cause irregular periods, acne, and excess hair growth. Participants will receive either Vitamin D 4000IU daily or a placebo (an inactive pill) for 6 months. Researchers want to see if Vitamin D 4000IU daily can improve irregular periods and increase vitamin D levels. To join, you must be a female between 13 and 21, have PCOS, and have a vitamin D level between 6-29 ng/mL. The study aims to enroll 60 participants.
- Study design
- This is a double-blind, placebo-controlled, randomized study, meaning neither you nor the study team will know if you are receiving Vitamin D 4000IU daily or the placebo. It plans to include 60 participants.
- What's involved
- You would be followed for 6 months, with repeat blood tests at the start, 3 months, and 6 months. These tests include vitamin D, hormone levels, and blood sugar checks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for 6 months after starting the treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
At a glance
Conditions
NCT04355572
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Yale New Haven Children's Hospital
New Haven, Connecticutstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alla Vash-Margita, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Exclusion
What this trial measures
- Change in oligomenorrhea6 months
The change in oligomenorrhea, i.e restoration of monthly menses or improvement in the menstrual pattern during 6 months while enrolled in the trial based on self report
- Changes Vitamin D (25-hydroxyvitamin D) levelat enrollment, at 3 months after randomization and 6 months after randomization
25-hydroxyvitamin D level will be measured by liquid chromatography-mass spectrometry (LC-MS/MS) or immunoassay