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Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nazia Raja-Khan, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00907153
First received: May 21, 2009
Last updated: September 17, 2014
Last verified: September 2014
  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 Milton S. Hershey Medical Center:

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: 38
Study Start Date: May 2009
Study Completion Date: September 2014
Primary Completion Date: February 2014 (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.

The protocol has been modified by adding the following specific aim: To compare vascular function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. We are currently recruiting healthy women who are age and BMI similar to the PCOS women and measure their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular reactivity. These healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. They will not be enrolled in the placebo or Vitamin D randomization process as described above.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Nazia Raja-Khan, M.D. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

Publications:
Responsible Party: Nazia Raja-Khan, M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism, 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: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome
Vitamin D
Insulin resistance
Inflammation

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

ClinicalTrials.gov processed this record on November 25, 2014