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Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
This study has been completed.

First Received on May 21, 2009.   Last Updated on August 2, 2011   History of Changes
Sponsor: Penn State University
Information provided by: Penn State University
ClinicalTrials.gov Identifier: NCT00907153
  Purpose

The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.


Condition Intervention Phase
Polycystic Ovary Syndrome
Dietary Supplement: Vitamin D
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • The primary outcome will be to determine if vitamin D reduces insulin resistance compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduced Inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in psychological health and overall well-being [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viatmin D Dietary Supplement: Vitamin D
Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo by mouth once daily for 12 weeks

Detailed Description:

As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with PCOS. These adverse effects may ultimately increase the risk for serious long-term complications in PCOS, including type 2 diabetes and cardiovascular disease. The key objectives of this research study are to determine the effects of vitamin D supplementation on insulin resistance, inflammation, mood and overall well-being in women with PCOS.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of PCOS based on:

    • Eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and
    • Elevated testosterone levels

Exclusion Criteria:

  • Current Pregnancy or Nursing
  • Elevated calcium
  • Kidney Stones or kidney disease
  • Current use of vitamin D (other than a multivitamin)
  • Use of metformin or other insulin sensitizing drugs in the last 3 months
  • Elevated prolactin or untreated thyroid disease
  • Diabetes, Liver disease, Heart disease, or other serious medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907153

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Nazia Raja-Khan, M.D. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Nazia Raja-Khan, M.D., Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00907153     History of Changes
Other Study ID Numbers: 29714
Study First Received: May 21, 2009
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Polycystic Ovary Syndrome
Vitamin D
Insulin resistance
Inflammation

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2012