Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS) - Full Text View

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:

MedlinePlus related topics: Diabetes Medicines Polycystic Ovary Syndrome Vitamin D

U.S. FDA Resources

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