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

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