Clinical trial NCT00907153: Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Official title: Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Vitamin D
Insulin resistance
Inflammation
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Systolic Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Diastolic Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Fasting Glucose
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Fasting Insulin
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean 2-hour Glucose
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean 2-hour Insulin
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Total Cholesterol
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean HDL Cholesterol
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean LDL Cholesterol
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Triglycerides
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Total Testosterone
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Free Testosterone
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change From Baseline in Mean 25-hydroxyvitamin D
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Vitamin D Binding Protein
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)
timeFrame: Baseline and 12 weeks
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Nazia Raja-Khan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raja-Khan N, Shah J, Stetter CM, Lott ME, Kunselman AR, Dodson WC, Legro RS. High-dose vitamin D supplementation and measures of insulin sensitivity in polycystic ovary syndrome: a randomized, controlled pilot trial. Fertil Steril. 2014 Jun;101(6):1740-6. doi: 10.1016/j.fertnstert.2014.02.021. Epub 2014 Mar 14.