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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04355572
Status
Recruiting
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Conditions

  • Polycystic Ovarian Syndrome in Adolescent Females
  • Vitamin D Deficiency

Eligibility Criteria

Sex
FEMALE
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Vitamin D 4000IU daily — DRUG
    Randomized to receive vitamin D 4000IU daily
  • Placebo — DRUG
    Randomized to placebo daily

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Change in oligomenorrhea [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Children's HospitalNew HavenConnecticut06510
Alla Vash-Margita, Principal Investigator, MD
[email protected]
203-785-7409
Kathleen Miclette, nurse coordinator, RN
[email protected]
203-444-3720
Alla Vash-Margita, Associate Professor, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Yale New Haven Children's Hospital· New Haven, CT

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