Vitamin D replacement for adolescent females with PCOS and low vitamin D

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized, placebo-controlled trial at Yale New Haven Children's Hospital enrolling postmenarchal females (13–21) who meet modified Rotterdam criteria for PCOS and have serum vitamin D 6–29 ng/mL. Participants are randomized to 4,000 IU vitamin D daily or matching placebo and followed for six months with lab testing at baseline, 3 months, and 6 months. Key measurements include AMH, vitamin D, lipid profile, glucose and insulin, androgen testing, and female hormone testing while participants and investigators remain blinded. Patients with severe deficiency (≤5 ng/mL) or other exclusionary conditions are managed clinically rather than randomized.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale New Haven Children's Hospital
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Alla Vash-Margita, MD — Yale University
• Study coordinator: Alla Vash-Margita, MD
• Email: alla.vash-margita@yale.edu
• Phone: 203-785-4010

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vitamin D Supplementation in Children with Irritable Bowel Syndrome

  This study tests whether giving vitamin D to children with IBS and low vitamin D levels can improve their IBS symptoms compared with a placebo.

  Recruiting Aziz Bhatti Shaheed Teaching Hospital · Gujrat, Punjab Province · NCT07914478

• Vitamin D and dental implant osseointegration in adults with deficiency

  This study tests whether giving vitamin D helps improve how well dental implants fuse with bone in adults who are deficient.

  Recruiting Future University in Egypt · Cairo, New Cairo · NCT07684404

• Vitamin D2 with Calcitriol in kids with cholestasis and vitamin D deficiency

  This study tests whether adding calcitriol to vitamin D2 helps children with cholestasis and vitamin D deficiency reach healthier vitamin D levels.

  Recruiting Phase 4 Chulalongkorn University · Bangkok · NCT07670611

• Vitamin D and the body's anti-inflammatory response in gum disease

  This study tests whether vitamin D can modulate the body's anti-inflammatory response in people with gum disease.

  Recruiting Recep Tayyip Erdogan University Training and Research Hospital · Rize · NCT07636733

• Bone Myoregulation and Posture in Vitamin D Deficiency

  This observational study tests whether adults with vitamin D deficiency differ in postural stability and muscle activity from healthy controls during a single-session, noninvasive assessment.

  Recruiting Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Istanbul · NCT07435935

• Adding exercise to vitamin D treatment for diabetic men with erectile dysfunction and low vitamin D.

  This trial will see if adding regular moderate treadmill walking to high‑dose vitamin D replacement helps men with type 2 diabetes, chronic erectile dysfunction, and low vitamin D levels.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07366970

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.