Actively Recruiting

Phase Not Applicable
Age: 13Years - 21Years
FEMALE
NCT04355572

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

Led by Yale University · Updated on 2026-02-23

60

Participants Needed

1

Research Sites

82 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 13Years - 21Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenarchal adolescent females aged 13 to 21
  • Meet modified Rotterdam criteria for PCOS
  • Serum vitamin D level between 6 and 29 ng/mL
Not Eligible

You will not qualify if you...

  • Other causes for hyperandrogenism
  • Chronic kidney diseases
  • Acquired or inherited calcium and vitamin D metabolic disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yale New Haven Children's Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

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Research Team

A

Alla Vash-Margita, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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