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

Phase 1/Phase 2
18 Years
45 Years
Open (Enrolling)
Polycystic Ovary Syndrome

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The primary outcome will be to determine if vitamin D reduces insulin resistance compared to placebo

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Nazia Raja-Khan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

February 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome
  • Vitamin D
  • Insulin resistance
  • Inflammation
  • Polycystic Ovary Syndrome



Penn State College of Medicine, Penn State Milton S Hershey Medical CenterHershey, Pennsylvania  17033