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

NCT ID: NCT00907153

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2014-09-30

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.

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Vitamin D; Insulin resistance; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D 300 mcg by mouth once daily for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo by mouth once daily for 12 weeks

Interventions

Vitamin D

Vitamin D 300 mcg by mouth once daily for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo by mouth once daily for 12 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nazia Raja-Khan

M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nazia Raja-Khan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Locations

Penn State College of Medicine, Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

Raja-Khan N, Shah J, Stetter CM, Lott ME, Kunselman AR, Dodson WC, Legro RS. High-dose vitamin D supplementation and measures of insulin sensitivity in polycystic ovary syndrome: a randomized, controlled pilot trial. Fertil Steril. 2014 Jun;101(6):1740-6. doi: 10.1016/j.fertnstert.2014.02.021. Epub 2014 Mar 14.

Reference Type: RESULT

PMID: 24636395 (View on PubMed)

Other Identifiers

29714

Identifier Type: -

Identifier Source: org_study_id