NCT00907153

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

Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Vitamin D 300 mcg by mouth once daily for 12 weeks
DRUG	Placebo	Placebo by mouth once daily for 12 weeks

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-02-01
• Completion: 2014-09-01
• First posted: 2009-05-22
• Last updated: 2017-12-19
• Results posted: 2017-12-19

Locations

1 site across 1 country: United States