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Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

NCT00743574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-08-13

Study results available
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Summary

The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI \> 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels \< 20 ng/mL).

Conditions

  • Polycystic Ovarian Syndrome
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D2 (Ergocalciferol)

50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)

DRUG

Medroxyprogesterone (Provera)

10mg, PO, daily for ten days

DIETARY_SUPPLEMENT

Vitamin D3 (Cholecalciferol)

2,000IU (or 2 tablets), PO, daily (supplements taken for three months)

DIETARY_SUPPLEMENT

Elemental Calcium

1,000mg (or 2 tablets), PO, daily (supplements taken for three months)

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Lubna Pal, MBBS,MRCOG,MSc. · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00743574 on ClinicalTrials.gov