Vitamin D for PCOS

Overseen By Alla Vash-Margita, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Hyperandrogenism, Chronic renal diseases, others

Compensation: Varies

Number of Visits: 5

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Alla Vash-Margita, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Adolescent females aged 13-21 with PCOS and low vitamin D levels (6-29 ng/mL) are eligible for this trial. They must meet modified Rotterdam criteria for PCOS, which helps diagnose the condition based on symptoms like irregular periods or excess male hormone levels.

Inclusion Criteria

I am a female aged 13-21 with PCOS and low vitamin D levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Treatment

Participants are randomized to receive either vitamin D supplement or placebo and followed for 6 months with repeat laboratory testing and depression assessments

6 months

3 visits (in-person) at randomization, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, and those with low vitamin D levels are offered treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Vitamin D

Trial Overview The study is testing if taking Vitamin D supplements (4000IU daily) affects clinical and psychological aspects of PCOS compared to a placebo. It's a double-blind trial, meaning neither participants nor researchers know who gets Vitamin D or the placebo until it ends.

How Is the Trial Designed?

Group I: Vitamin D Supplement Experimental Treatment 1 Intervention

Patients will take vitamin D tablet with 4,000IU daily for 6 months.

Group II: Placebo Placebo Group 1 Intervention

Patients will take placebo for 6 months

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+