Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907153
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Nazia Raja-Khan, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE May 21, 2009
First Posted Date  ICMJE May 22, 2009
Results First Submitted Date  ICMJE March 10, 2017
Results First Posted Date  ICMJE December 19, 2017
Last Update Posted Date December 19, 2017
Study Start Date  ICMJE May 2009
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) [ Time Frame: 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))]).
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
The primary outcome will be to determine if vitamin D reduces insulin resistance compared to placebo [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and 12 weeks ]
    Glucose was assessed after 12 hours of fasting.
  • Change From Baseline in Mean Fasting Insulin [ Time Frame: Baseline and 12 weeks ]
    Insulin was assessed after 12 hours of fasting.
  • Change From Baseline in Mean 2-hour Glucose [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline and 12 weeks ]
    Lipid profile was assessed after 12 hours of fasting.
  • Change From Baseline in Mean HDL Cholesterol [ Time Frame: Baseline and 12 weeks ]
    Lipid profile was assessed after 12 hours of fasting.
  • Change From Baseline in Mean LDL Cholesterol [ Time Frame: Baseline and 12 weeks ]
    Lipid profile was assessed after 12 hours of fasting.
  • Change From Baseline in Mean Triglycerides [ Time Frame: Baseline and 12 weeks ]
    Lipid profile was assessed after 12 hours of fasting.
  • Change From Baseline in Mean Total Testosterone [ Time Frame: 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 [ Time Frame: Baseline and 12 weeks ]
    Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • Reduced Inflammation [ Time Frame: 12 weeks ]
  • Improvement in psychological health and overall well-being [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: November 20, 2017)
  • Change From Baseline in Mean 25-hydroxyvitamin D [ Time Frame: Baseline and 12 weeks ]
    Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
  • Change From Baseline in Mean Vitamin D Binding Protein [ Time Frame: Baseline and 12 weeks ]
    Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
  • Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH) [ Time Frame: Baseline and 12 weeks ]
    Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Official Title  ICMJE Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Dietary Supplement: Vitamin D
    Vitamin D 300 mcg by mouth once daily for 12 weeks
  • Drug: Placebo
    Placebo by mouth once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: Vitamin D
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2017)
36
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2009)
24
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907153
Other Study ID Numbers  ICMJE 29714
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nazia Raja-Khan, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nazia Raja-Khan, M.D. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP