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The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Vitamin D 300 mcg by mouth once daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) | 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))]). | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP) | High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation. | Baseline and 12 weeks |
| Change From Baseline in Mean Systolic Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 25-hydroxyvitamin D | Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay. | Baseline and 12 weeks |
| Change From Baseline in Mean Vitamin D Binding Protein |
Inclusion Criteria:
Diagnosis of PCOS based on:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazia Raja-Khan, M.D. | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24636395 | Result | 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. |
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28 of 36 participants were randomized. Of those not randomized, 3 did not meet inclusion criteria, 3 declined to participate, and 2 were not randomized for other reasons.
36 patients were screened for eligibility between July 2009 and November 2010 at Medicine and Obstetrics and Gynecology clinics at an academic medical center in Hershey, PA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks |
| FG001 | Placebo | Placebo: Placebo by mouth once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks |
| BG001 | Placebo | Placebo: Placebo by mouth once daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) | 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))]). | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 weeks |
|
Twelve weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D | Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nazia Raja-Khan | Penn State Hershey Medical Center | 717-531-8395 | nrajakhan@psu.edu |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Drug |
Placebo by mouth once daily for 12 weeks |
|
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
| Baseline and 12 weeks |
| Change From Baseline in Mean Diastolic Blood Pressure | Blood pressure was measured in the right arm in the sitting position after a 15-minute rest. | Baseline and 12 weeks |
| Change From Baseline in Mean Fasting Glucose | Glucose was assessed after 12 hours of fasting. | Baseline and 12 weeks |
| Change From Baseline in Mean Fasting Insulin | Insulin was assessed after 12 hours of fasting. | Baseline and 12 weeks |
| Change From Baseline in Mean 2-hour Glucose | 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). | Baseline and 12 weeks |
| Change From Baseline in Mean 2-hour Insulin | 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). | Baseline and 12 weeks |
| Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120) | 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). | Baseline and 12 weeks |
| Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 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. | Baseline and 12 weeks |
| Change From Baseline in Mean Total Cholesterol | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks |
| Change From Baseline in Mean HDL Cholesterol | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks |
| Change From Baseline in Mean LDL Cholesterol | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks |
| Change From Baseline in Mean Triglycerides | Lipid profile was assessed after 12 hours of fasting. | Baseline and 12 weeks |
| Change From Baseline in Mean Total Testosterone | Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS. | Baseline and 12 weeks |
| Change From Baseline in Mean Free Testosterone | Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS. | Baseline and 12 weeks |
Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
| Baseline and 12 weeks |
| Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH) | Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance. | Baseline and 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mm hg |
|
| 25-hydroxyvitamin D | Mean | Standard Deviation | ng/mL |
|
| Vitamin D binding protein | Mean | Standard Deviation | mg/dL |
|
| Intact parathyroid hormone (i-PTH) | Mean | Standard Deviation | pg/mL |
|
| Fasting glucose | Mean | Standard Deviation | mg/dL |
|
| Fasting insulin | Mean | Standard Deviation | uU/mL |
|
| 2-hour glucose | Mean | Standard Deviation | mg/dL |
|
| 2-hour insulin | Mean | Standard Deviation | uU/mL |
|
| Insulin sensitivity index 0,120 | 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). | Mean | Standard Deviation | mg·l^2/mmol·mU·min |
|
| Quantitative Insulin Sensitivity Check Index (QUICKI) | The primary outcome was quantitative insulin sensitivity check index (QUICKI), 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))]). | Mean | Standard Deviation | units on a scale |
|
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5. | Mean | Standard Deviation | units on a scale |
|
| Total cholesterol | Mean | Standard Deviation | mg/dL |
|
| HDL cholesterol | Mean | Standard Deviation | mg/dL |
|
| LDL cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglyecrides | Mean | Standard Deviation | mg/dL |
|
| High sensitive C-reactive protein (hsCRP) | Mean | Standard Deviation | mg/L |
|
| Total testosterone | Mean | Standard Deviation | ng/dL |
|
| Free testosterone | Mean | Standard Deviation | ng/dL |
|
Placebo: Placebo by mouth once daily for 12 weeks
|
|
|
| Secondary | Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP) | High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/L | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Systolic Blood Pressure | Blood pressure was measured in the right arm in the sitting position after a 15-minute rest. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Diastolic Blood Pressure | Blood pressure was measured in the right arm in the sitting position after a 15-minute rest. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Fasting Glucose | Glucose was assessed after 12 hours of fasting. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Fasting Insulin | Insulin was assessed after 12 hours of fasting. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | uU/mL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean 2-hour Glucose | 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). | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean 2-hour Insulin | 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). | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | uU/mL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120) | 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). | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg·l^2/mmol·mU·min | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 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. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Total Cholesterol | Lipid profile was assessed after 12 hours of fasting. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean HDL Cholesterol | Lipid profile was assessed after 12 hours of fasting. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean LDL Cholesterol | Lipid profile was assessed after 12 hours of fasting. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Triglycerides | Lipid profile was assessed after 12 hours of fasting. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Total Testosterone | Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | ng/dL | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Mean Free Testosterone | Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | ng/dL | Baseline and 12 weeks |
|
|
|
|
| Other Pre-specified | Change From Baseline in Mean 25-hydroxyvitamin D | Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | ng/mL | Baseline and 12 weeks |
|
|
|
|
| Other Pre-specified | Change From Baseline in Mean Vitamin D Binding Protein | Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline and 12 weeks |
|
|
|
|
| Other Pre-specified | Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH) | Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance. | All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to. | Posted | Mean | 95% Confidence Interval | pg/mL | Baseline and 12 weeks |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Placebo | Placebo: Placebo by mouth once daily for 12 weeks | 0 | 15 | 0 | 15 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |