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

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ClinicalTrials.gov Identifier: NCT00907153
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Dietary Supplement: Vitamin D Drug: Placebo Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
Study Start Date : May 2009
Primary Completion Date : February 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. The primary outcome will be to determine if vitamin D reduces insulin resistance compared to placebo [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Reduced Inflammation [ Time Frame: 12 weeks ]
  2. Improvement in psychological health and overall well-being [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907153

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

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
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Nazia Raja-Khan, Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome
Vitamin D
Insulin resistance

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