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

Milton S. Hershey Medical Center36 enrolled

Overview

The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

Vitamin DDIETARY_SUPPLEMENT

Vitamin D 300 mcg by mouth once daily for 12 weeks

PlaceboDRUG

Placebo by mouth once daily for 12 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)

Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/\[log(I(0)) + log(G(0))\]).