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

Phase 1

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Dietary Supplement: Vitamin D
Drug: Placebo

Registration Number: NCT00907153

Lead Sponsor: Milton S. Hershey Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)	Baseline and 12 weeks	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/\[log(I(0)) + log(G(0))\]).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)	Baseline and 12 weeks	High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
Change From Baseline in Mean Systolic Blood Pressure	Baseline and 12 weeks	Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Change From Baseline in Mean Diastolic Blood Pressure	Baseline and 12 weeks	Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Change From Baseline in Mean Fasting Glucose	Baseline and 12 weeks	Glucose was assessed after 12 hours of fasting.
Change From Baseline in Mean Fasting Insulin	Baseline and 12 weeks	Insulin was assessed after 12 hours of fasting.
Change From Baseline in Mean 2-hour Glucose	Baseline and 12 weeks	Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
Change From Baseline in Mean 2-hour Insulin	Baseline and 12 weeks	Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)	Baseline and 12 weeks	Participants underwent a 75-g oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 120 minutes and used to calculate the insulin sensitivity index (ISI0,120). The ISI 0,120 = the glucose uptake rate divided by the mean plasma glucose divided by the log(mean serum insulin).
Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Baseline and 12 weeks	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a validated measure of insulin resistance based on fasting insulin and glucose. HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5.
Change From Baseline in Mean Total Cholesterol	Baseline and 12 weeks	Lipid profile was assessed after 12 hours of fasting.
Change From Baseline in Mean HDL Cholesterol	Baseline and 12 weeks	Lipid profile was assessed after 12 hours of fasting.
Change From Baseline in Mean LDL Cholesterol	Baseline and 12 weeks	Lipid profile was assessed after 12 hours of fasting.
Change From Baseline in Mean Triglycerides	Baseline and 12 weeks	Lipid profile was assessed after 12 hours of fasting.
Change From Baseline in Mean Total Testosterone	Baseline and 12 weeks	Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Change From Baseline in Mean Free Testosterone	Baseline and 12 weeks	Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.