Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing Vitamin D 4000IU daily for Polycystic Ovarian Syndrome in Adolescent Females

This study is a double blind, dummy treatment (placebo) controlled, randomly assigned trial of study subjects with PCOS and low vitamin D to 2 groups- dummy treatment (placebo) and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period

Official registry: https://clinicaltrials.gov/study/NCT04355572 · Yale University · enrollment listed as 60

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Vitamin D 4000IU daily, or Placebo. The registry lists allocation as randomized. This study is a double blind, dummy treatment (placebo) controlled, randomly assigned trial of study subjects with PCOS and low vitamin D to 2 groups- dummy treatment (placebo) and vitamin D replacement.

They plan to enroll about 60 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Vitamin D 4000IU daily, Placebo

Primary outcome (registry wording): Change in oligomenorrhea

Who it is for (from inclusion criteria)

  • Ages 13 Years to 21 Years
  • Women only
  • \- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng/mL

Public study contact (from the registry)

Alla Vash-Margita, MD

203-785-4010

alla.vash-margita@yale.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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NCT05819853 · Official ClinicalTrials.gov record · University of Colorado, Denver

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Determinants of Insulin Sensitivity by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

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NCT05950282 · Official ClinicalTrials.gov record · Ali Chappell

FAQ about this NCT record

Is NCT04355572 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04355572?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04355572?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary