A Phase 1/2 interventional study of Vitamin D and Placebo in Polycystic Ovary Syndrome, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Milton S. Hershey Medical Center · Phase 1/2, Interventional, and Treatment
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.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 36 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Milton S. Hershey Medical Center is the lead sponsor of 491 studies on the registry; 59 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 44 (76%) have results posted.
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Diagnosis of PCOS based on:
Exclusion Criteria:
Dietary Supplement: Vitamin D
Drug: Placebo
Vitamin D 300 mcg by mouth once daily for 12 weeks
Placebo by mouth once daily for 12 weeks
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/\[log(I(0)) + log(G(0))\]).
Time frame: Baseline and 12 weeks
Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
Time frame: Baseline and 12 weeks
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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Fasting Glucose
Glucose was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Fasting Insulin
Insulin was assessed after 12 hours of fasting.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Total Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Change From Baseline in Mean HDL Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Change From Baseline in Mean LDL Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Change From Baseline in Mean Triglycerides
Lipid profile was assessed after 12 hours of fasting.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Change From Baseline in Mean 25-hydroxyvitamin D
Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
Time frame: Baseline and 12 weeks
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.
Time frame: 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.
Time frame: Baseline and 12 weeks
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.
| Milestone | Vitamin D | Placebo |
|---|---|---|
| Started | 13 | 15 |
| Completed | 11 | 11 |
| Not completed | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 3 |
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/\[log(I(0)) + log(G(0))\]).
| units on a scale | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) | -0.008 (-0.020 to 0.004) | 0.009 (-0.003 to 0.021) |
High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
| mg/L | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP) | 0.90 (-2.46 to 4.27) | 2.04 (-1.37 to 5.45) |
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
| mm Hg | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Systolic Blood Pressure | 0.64 (-7.13 to 8.42) | 4.29 (-3.15 to 11.74) |
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
| mm Hg | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Diastolic Blood Pressure | -0.91 (-4.96 to 3.14) | 5.60 (1.69 to 9.52) |
Glucose was assessed after 12 hours of fasting.
| mg/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Fasting Glucose | -0.70 (-7.96 to 6.56) | -6.98 (-14.31 to 0.34) |
Insulin was assessed after 12 hours of fasting.
| uU/mL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Fasting Insulin | 13.04 (-3.96 to 30.05) | -0.80 (-18.03 to 16.43) |
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).
| mg/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean 2-hour Glucose | -11.66 (-33.22 to 9.89) | 1.14 (-20.10 to 22.38) |
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).
| uU/mL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean 2-hour Insulin | -62.02 (-124.5 to 0.49) | 13.06 (-47.94 to 74.06) |
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).
| mg·l^2/mmol·mU·min | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120) | 6.67 (-16.87 to 30.21) | 5.94 (-17.77 to 29.65) |
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.
| units on a scale | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 2.57 (-0.90 to 6.03) | -0.51 (-4.01 to 2.99) |
Lipid profile was assessed after 12 hours of fasting.
| mg/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Total Cholesterol | -1.69 (-19.04 to 15.66) | -1.80 (-19.55 to 15.95) |
Lipid profile was assessed after 12 hours of fasting.
| mg/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean HDL Cholesterol | -0.70 (-6.52 to 5.12) | 1.23 (-4.68 to 7.14) |
Lipid profile was assessed after 12 hours of fasting.
| mg/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean LDL Cholesterol | -0.12 (-14.70 to 14.46) | -0.40 (-15.24 to 14.45) |
Lipid profile was assessed after 12 hours of fasting.
| mg/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Triglycerides | -2.21 (-34.11 to 29.69) | -12.44 (-44.68 to 19.80) |
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
| ng/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Total Testosterone | 3.01 (-8.05 to 14.06) | 10.16 (-1.16 to 21.47) |
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
| ng/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Free Testosterone | 2.67 (-1.29 to 6.63) | 5.82 (1.82 to 9.82) |
Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
| ng/mL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean 25-hydroxyvitamin D | 45.63 (33.50 to 57.76) | 1.32 (-10.93 to 13.58) |
Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
| mg/dL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Vitamin D Binding Protein | 1.01 (-1.60 to 3.62) | -0.55 (-3.14 to 2.04) |
Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
| pg/mL | Vitamin D | Placebo |
|---|---|---|
| Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH) | -24.28 (-39.80 to -8.76) | -16.45 (-31.40 to -1.49) |
Collected over Twelve weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D | — | 0/13 (0%) | 0/13 (0%) |
| Placebo | — | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Mean | 28.2 ± 5.2 | 28.7 ± 5.6 | 28.5 ± 5.3 |
| Sex: Female, Male(Participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Female | 13 | 15 | 28 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 10 | 14 | 24 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| United States | 13 | 15 | 28 |
| Body Mass Index (BMI)(kg/m2) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Mean | 37.20 ± 4.53 | 35.09 ± 9.81 | 36.1 ± 7.8 |
| Systolic blood pressure(mm Hg) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Mean | 117.46 ± 10.00 | 113.91 ± 10.21 | 115.56 ± 10.11 |
| Diastolic blood pressure(mm hg) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Mean | 79.08 ± 8.28 | 74.88 ± 7.72 | 76.83 ± 7.98 |
| 25-hydroxyvitamin D(ng/mL) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Mean | 19.95 ± 9.47 | 22.20 ± 6.86 | 21.15 ± 8.10 |
16 further baseline measures are reported on the registry.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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