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

Study Overview
=================
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.

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

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br> | Dietary Supplement: Vitamin D<br>* Vitamin D 300 mcg by mouth once daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo by mouth once daily for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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))]). | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP) | High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation. | Baseline and 12 weeks | 
| Change From Baseline in Mean Systolic Blood Pressure | Blood pressure was measured in the right arm in the sitting position after a 15-minute rest. | Baseline and 12 weeks | 
| Change From Baseline in Mean Diastolic Blood Pressure | Blood pressure was measured in the right arm in the sitting position after a 15-minute rest. | Baseline and 12 weeks | 
| Change From Baseline in Mean Fasting Glucose | Glucose was assessed after 12 hours of fasting. | Baseline and 12 weeks | 
| Change From Baseline in Mean Fasting Insulin | Insulin was assessed after 12 hours of fasting. | Baseline and 12 weeks | 
| Change From Baseline in Mean 2-hour Glucose | 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). | Baseline and 12 weeks | 
| Change From Baseline in Mean 2-hour Insulin | 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). | Baseline and 12 weeks | 
| Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120) | 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). | Baseline and 12 weeks | 
| Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 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. | Baseline and 12 weeks | 
| Change From Baseline in Mean Total Cholesterol | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks | 
| Change From Baseline in Mean HDL Cholesterol | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks | 
| Change From Baseline in Mean LDL Cholesterol | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks | 
| Change From Baseline in Mean Triglycerides | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks | 
| Change From Baseline in Mean Total Testosterone | Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS. | Baseline and 12 weeks | 
| Change From Baseline in Mean Free Testosterone | Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS. | Baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary Syndrome, Vitamin D, Insulin resistance, Inflammation