Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
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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. |
- 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 ]
- 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 ]
| Estimated Enrollment: | 28 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated 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 |
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| Contact: Barb Scheetz, B.S. | 717-531-4483 | bscheetz@psu.edu |
| Contact: Nazia Raja-Khan, M.D. | 717-531-8395 | nrajakhan@psu.edu |
| United States, Pennsylvania | |
| Penn State College of Medicine, Penn State Milton S Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Barb Scheetz, B.S. 717-531-4483 bscheetz@psu.edu | |
| Contact: Nazia Raja-Khan, M.D. 717-531-8395 nrajakhan@psu.edu | |
| Principal Investigator: Nazia Raja-Khan, M.D. | |
| 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., 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: | February 21, 2013 |
| 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 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 16, 2013