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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)

Launched by YALE UNIVERSITY · Apr 17, 2020

Trial Information

Current as of November 06, 2025

Recruiting

Keywords

Anti Mullerian Hormone (Amh)

ClinConnect Summary

This clinical trial is investigating how vitamin D replacement affects the health and well-being of adolescent females who are at risk for Polycystic Ovarian Syndrome (PCOS) and have low levels of vitamin D. The study will include young women aged 13 to 21 who have been diagnosed with PCOS and have a specific range of vitamin D levels in their blood. Participants will be divided into two groups: one group will receive vitamin D supplements, while the other will receive a placebo, which is a harmless substance that looks like the supplement but has no active ingredients. Neither the participants nor the researchers will know who is receiving which treatment until the study is completed.

To be eligible for this trial, participants must be postmenarchal (meaning they have started their menstrual periods) and have low vitamin D levels, specifically between 6 and 29 ng/mL. Those with other conditions that could affect hormone levels or kidney problems will not be included. Throughout the study, participants can expect regular check-ins and assessments to monitor their health and any changes in their symptoms. This research aims to better understand the potential benefits of vitamin D for young women dealing with PCOS and vitamin D deficiency.

Gender

FEMALE

Eligibility criteria

  • 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.

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Alla Vash-Margita, MD

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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