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Completed

NCT Number: NCT00907153

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

The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Vitamin D 300 mcg by mouth once daily for 12 weeks

Placebo

Drug

Placebo by mouth once daily for 12 weeks

Primary outcomes

  1. 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))]).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change From Baseline in Mean Fasting Glucose

    Time frame: Baseline and 12 weeks

    Glucose was assessed after 12 hours of fasting.

  5. Change From Baseline in Mean Fasting Insulin

    Time frame: Baseline and 12 weeks

    Insulin was assessed after 12 hours of fasting.

  6. 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).

  7. 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).

  8. 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).

  9. 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.

  10. Change From Baseline in Mean Total Cholesterol

    Time frame: Baseline and 12 weeks

    Lipid profile was assessed after 12 hours of fasting.

  11. Change From Baseline in Mean HDL Cholesterol

    Time frame: Baseline and 12 weeks

    Lipid profile was assessed after 12 hours of fasting.

  12. Change From Baseline in Mean LDL Cholesterol

    Time frame: Baseline and 12 weeks

    Lipid profile was assessed after 12 hours of fasting.

  13. Change From Baseline in Mean Triglycerides

    Time frame: Baseline and 12 weeks

    Lipid profile was assessed after 12 hours of fasting.

  14. 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.

  15. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 22, 2009
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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