RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04355572

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Other causes for hyperandrogenism,
  2. * Chronic renal diseases,
  3. * Acquired or inherited calcium and vitamin D metabolic disorders.

Contacts and Locations

Study Contact

Alla Vash-Margita, MD
CONTACT
203-785-4010
alla.vash-margita@yale.edu

Principal Investigator

Alla Vash-Margita, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Children's Hospital
New Haven, Connecticut, 06510
United States

Collaborators and Investigators

Sponsor: Yale University

  • Alla Vash-Margita, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2025-07
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Anti-Mullerian Hormone (AMH)

Additional Relevant MeSH Terms

  • Polycystic Ovarian Syndrome in Adolescent Females
  • Vitamin D Deficiency