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

NCT04355572 | Recruiting DMC

• 2 other identifiers: 2000028054000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovarian Syndrome in Adolescent Females; Vitamin D Deficiency

Keywords

Anti-Mullerian Hormone (AMH)

Outcome Measures

Primary Outcomes (2)

• Change in oligomenorrhea

  The change in oligomenorrhea, i.e restoration of monthly menses or improvement in the menstrual pattern during 6 months while enrolled in the trial based on self report

  6 months

• Changes Vitamin D (25-hydroxyvitamin D) level

  25-hydroxyvitamin D level will be measured by liquid chromatography-mass spectrometry (LC-MS/MS) or immunoassay

  at enrollment, at 3 months after randomization and 6 months after randomization

Secondary Outcomes (7)

• Change in DHEAS level

  at enrollment, at 3 months after randomization and 6 months after randomization

• Changes in Androstenedione level

  at enrollment, at 3 months after randomization and 6 months after randomization

• Change in Anti-Mullerian hormone (AMH) level

  at enrollment, at 3 months after randomization and 6 months after randomization

• Change in testosterone level

  at enrollment, at 3 months after randomization and 6 months after randomization

• Change in Hirsutism

  at enrollment, at 3 months after randomization and 6 months after randomization

Study Arms (2)

Vitamin D Supplement

EXPERIMENTAL

Patients will take vitamin D tablet with 4,000IU daily for 6 months.

Drug: Vitamin D 4000IU daily

Placebo

PLACEBO COMPARATOR

Patients will take placebo for 6 months

Drug: Placebo

Interventions

Vitamin D 4000IU daily DRUG

Randomized to receive vitamin D 4000IU daily

Vitamin D Supplement

Placebo DRUG

Randomized to placebo daily

Placebo

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Other causes for hyperandrogenism,
• Chronic renal diseases,
• Acquired or inherited calcium and vitamin D metabolic disorders.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alla Vash-Margita, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alla Vash-Margita, MD

CONTACT

203-785-4010; alla.vash-margita@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will be blinded to treatment modality until the end of the trial period
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)