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

NCT04355572 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-23

No results posted yet for this study

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

Interventions

DRUG

Vitamin D 4000IU daily

Randomized to receive vitamin D 4000IU daily

DRUG

Placebo

Randomized to placebo daily

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Alla Vash-Margita, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355572 on ClinicalTrials.gov