Recruiting

Vitamin DEvaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)

Sponsor:

Yale University

Code:

NCT04355572

Conditions

Polycystic Ovarian Syndrome in Adolescent Females

Vitamin D Deficiency

Eligibility Criteria

Sex: Female

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Vitamin D 4000IU daily

Placebo

Study Details

Brief summary:

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

Conditions

Polycystic Ovarian Syndrome in Adolescent Females

Vitamin D Deficiency

Study ID

NCT04355572

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 13 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vitamin D Supplement

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

placebo comparator: Placebo

Patients will take placebo for 6 months

Interventions

Vitamin D 4000IU daily

Randomized to receive vitamin D 4000IU daily

Placebo

Randomized to placebo daily

Primary outcome measure

Change in oligomenorrhea [ Time Frame: 6 months ]
Changes Vitamin D (25-hydroxyvitamin D) level [ Time Frame: at enrollment, at 3 months after randomization and 6 months after randomization ]

Central Contacts and Locations

Central contacts

Alla Vash-Margita, MD

203-785-4010 alla.vash-margita@yale.edu

Locations

Yale New Haven Children's Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Alla Vash-Margita, Principal Investigator, MD

203-785-7409 alla.vash-margita@yale.edu

Kathleen Miclette, nurse coordinator, RN

203-444-3720 kathleen.miclette@ynhh.org

Principal Investigator:

Alla Vash-Margita, Associate Professor, MD

More Information

Sponsor

Yale University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

Anti-Mullerian Hormone (AMH)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-20.