Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, Vitamin D, Insulin resistance, Inflammation
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D 300 mcg by mouth once daily for 12 weeks
DRUGPlacebo
Placebo by mouth once daily for 12 weeks
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean 2-hour Insulin | 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 Triglycerides | Baseline and 12 weeks | Lipid profile was assessed after 12 hours of fasting. |
| Change From Baseline in Mean Total Testosterone | 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 | 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 High Sensitive C-reactive Protein (hsCRP) | 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 | 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 | 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 | Baseline and 12 weeks | Glucose was assessed after 12 hours of fasting. |
| Change From Baseline in Mean Fasting Insulin | Baseline and 12 weeks | Insulin was assessed after 12 hours of fasting. |
| Change From Baseline in Mean 2-hour Glucose | 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) | 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) | 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 | Baseline and 12 weeks | Lipid profile was assessed after 12 hours of fasting. |
| Change From Baseline in Mean HDL Cholesterol | Baseline and 12 weeks | Lipid profile was assessed after 12 hours of fasting. |
| Change From Baseline in Mean LDL Cholesterol | Baseline and 12 weeks | Lipid profile was assessed after 12 hours of fasting. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH) | Baseline and 12 weeks | Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance. |
| Change From Baseline in Mean 25-hydroxyvitamin D | Baseline and 12 weeks | Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay. |
| Change From Baseline in Mean Vitamin D Binding Protein | Baseline and 12 weeks | Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks | 13 |
| Placebo Placebo: Placebo by mouth once daily for 12 weeks | 15 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Vitamin D | Placebo | Total |
|---|---|---|---|
| 25-hydroxyvitamin D | 19.95 ng/mL STANDARD_DEVIATION 9.47 | 22.20 ng/mL STANDARD_DEVIATION 6.86 | 21.15 ng/mL STANDARD_DEVIATION 8.1 |
| 2-hour glucose | 122.08 mg/dL STANDARD_DEVIATION 36.29 | 110.07 mg/dL STANDARD_DEVIATION 23.68 | 115.64 mg/dL STANDARD_DEVIATION 30.22 |
| 2-hour insulin | 214.69 uU/mL STANDARD_DEVIATION 146.41 | 107.07 uU/mL STANDARD_DEVIATION 55.2 | 157.04 uU/mL STANDARD_DEVIATION 118.72 |
| Age, Continuous | 28.2 years STANDARD_DEVIATION 5.2 | 28.7 years STANDARD_DEVIATION 5.6 | 28.5 years STANDARD_DEVIATION 5.3 |
| Body Mass Index (BMI) | 37.20 kg/m2 STANDARD_DEVIATION 4.53 | 35.09 kg/m2 STANDARD_DEVIATION 9.81 | 36.1 kg/m2 STANDARD_DEVIATION 7.8 |
| Diastolic blood pressure | 79.08 mm hg STANDARD_DEVIATION 8.28 | 74.88 mm hg STANDARD_DEVIATION 7.72 | 76.83 mm hg STANDARD_DEVIATION 7.98 |
| Fasting glucose | 84.92 mg/dL STANDARD_DEVIATION 9.46 | 83.73 mg/dL STANDARD_DEVIATION 9.33 | 84.29 mg/dL STANDARD_DEVIATION 9.23 |
| Fasting insulin | 26.31 uU/mL STANDARD_DEVIATION 9.6 | 27.13 uU/mL STANDARD_DEVIATION 15.79 | 26.75 uU/mL STANDARD_DEVIATION 13.05 |
| Free testosterone | 19.08 ng/dL STANDARD_DEVIATION 15.79 | 14.00 ng/dL STANDARD_DEVIATION 10.88 | 16.89 ng/dL STANDARD_DEVIATION 13.33 |
| HDL cholesterol | 45.54 mg/dL STANDARD_DEVIATION 17.6 | 37.00 mg/dL STANDARD_DEVIATION 10.83 | 40.96 mg/dL STANDARD_DEVIATION 14.74 |
| High sensitive C-reactive protein (hsCRP) | 7.95 mg/L STANDARD_DEVIATION 5.24 | 4.42 mg/L STANDARD_DEVIATION 4.34 | 6.1 mg/L STANDARD_DEVIATION 5 |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 5.47 units on a scale STANDARD_DEVIATION 1.82 | 5.80 units on a scale STANDARD_DEVIATION 3.9 | 5.65 units on a scale STANDARD_DEVIATION 2.93 |
| Insulin sensitivity index 0,120 | 55.55 mg·l^2/mmol·mU·min STANDARD_DEVIATION 23.26 | 63.56 mg·l^2/mmol·mU·min STANDARD_DEVIATION 16.37 | 59.84 mg·l^2/mmol·mU·min STANDARD_DEVIATION 19.57 |
| Intact parathyroid hormone (i-PTH) | 40.81 pg/mL STANDARD_DEVIATION 27.34 | 33.17 pg/mL STANDARD_DEVIATION 17.73 | 36.72 pg/mL STANDARD_DEVIATION 22.19 |
| LDL cholesterol | 98.62 mg/dL STANDARD_DEVIATION 36.96 | 117.33 mg/dL STANDARD_DEVIATION 28.56 | 108.64 mg/dL STANDARD_DEVIATION 33.47 |
| Quantitative Insulin Sensitivity Check Index (QUICKI) | 0.302 units on a scale STANDARD_DEVIATION 0.014 | 0.307 units on a scale STANDARD_DEVIATION 0.029 | 0.305 units on a scale STANDARD_DEVIATION 0.022 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 14 Participants | 24 Participants |
| Region of Enrollment United States | 13 participants | 15 participants | 28 participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Systolic blood pressure | 117.46 mm Hg STANDARD_DEVIATION 10 | 113.91 mm Hg STANDARD_DEVIATION 10.21 | 115.56 mm Hg STANDARD_DEVIATION 10.11 |
| Total cholesterol | 172.00 mg/dL STANDARD_DEVIATION 42.7 | 184.27 mg/dL STANDARD_DEVIATION 32.52 | 178.57 mg/dL STANDARD_DEVIATION 37.38 |
| Total testosterone | 54.23 ng/dL STANDARD_DEVIATION 28.16 | 41.27 ng/dL STANDARD_DEVIATION 17.29 | 48.48 ng/dL STANDARD_DEVIATION 23.03 |
| Triglyecrides | 139.08 mg/dL STANDARD_DEVIATION 71.61 | 149.47 mg/dL STANDARD_DEVIATION 85.46 | 144.64 mg/dL STANDARD_DEVIATION 78.07 |
| Vitamin D binding protein | 30.46 mg/dL STANDARD_DEVIATION 8.53 | 31.95 mg/dL STANDARD_DEVIATION 7.54 | 31.34 mg/dL STANDARD_DEVIATION 8.04 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
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/\[log(I(0)) + log(G(0))\]).
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) | -0.008 units on a scale |
| Placebo | Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI) | 0.009 units on a scale |
p-value: 0.0595% CI: [-0.034, 0]Regression, Linear
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).
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean 2-hour Glucose | -11.66 mg/dL |
| Placebo | Change From Baseline in Mean 2-hour Glucose | 1.14 mg/dL |
p-value: 0.3995% CI: [-42.94, 17.34]Regression, Linear
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).
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean 2-hour Insulin | -62.02 uU/mL |
| Placebo | Change From Baseline in Mean 2-hour Insulin | 13.06 uU/mL |
p-value: 0.0995% CI: [-161.9, 11.78]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Diastolic Blood Pressure | -0.91 mm Hg |
| Placebo | Change From Baseline in Mean Diastolic Blood Pressure | 5.60 mm Hg |
p-value: 0.0295% CI: [-12.07, -0.96]Regression, Linear
Secondary
Change From Baseline in Mean Fasting Glucose
Glucose was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Fasting Glucose | -0.70 mg/dL |
| Placebo | Change From Baseline in Mean Fasting Glucose | -6.98 mg/dL |
p-value: 0.2295% CI: [-3.97, 16.54]Regression, Linear
Secondary
Change From Baseline in Mean Fasting Insulin
Insulin was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Fasting Insulin | 13.04 uU/mL |
| Placebo | Change From Baseline in Mean Fasting Insulin | -0.80 uU/mL |
p-value: 0.3395% CI: [-210.29, 37.98]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Free Testosterone | 2.67 ng/dL |
| Placebo | Change From Baseline in Mean Free Testosterone | 5.82 ng/dL |
p-value: 0.2595% CI: [-8.7, 2.41]Regression, Linear
Secondary
Change From Baseline in Mean HDL Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean HDL Cholesterol | -0.70 mg/dL |
| Placebo | Change From Baseline in Mean HDL Cholesterol | 1.23 mg/dL |
p-value: 0.6295% CI: [-10.12, 6.26]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP) | 0.90 mg/L |
| Placebo | Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP) | 2.04 mg/L |
p-value: 0.6295% CI: [-5.89, 3.62]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 2.57 units on a scale |
| Placebo | Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -0.51 units on a scale |
p-value: 0.2195% CI: [-1.84, 7.99]Regression, Linear
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).
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120) | 6.67 mg·l^2/mmol·mU·min |
| Placebo | Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120) | 5.94 mg·l^2/mmol·mU·min |
p-value: 0.9695% CI: [-32.59, 34.06]Regression, Linear
Secondary
Change From Baseline in Mean LDL Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean LDL Cholesterol | -0.12 mg/dL |
| Placebo | Change From Baseline in Mean LDL Cholesterol | -0.40 mg/dL |
p-value: 0.9895% CI: [-20.29, 20.85]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Systolic Blood Pressure | 0.64 mm Hg |
| Placebo | Change From Baseline in Mean Systolic Blood Pressure | 4.29 mm Hg |
p-value: 0.4895% CI: [-14.32, 7.02]Regression, Linear
Secondary
Change From Baseline in Mean Total Cholesterol
Lipid profile was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Total Cholesterol | -1.69 mg/dL |
| Placebo | Change From Baseline in Mean Total Cholesterol | -1.80 mg/dL |
p-value: 0.9995% CI: [-24.43, 24.64]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Total Testosterone | 3.01 ng/dL |
| Placebo | Change From Baseline in Mean Total Testosterone | 10.16 ng/dL |
p-value: 0.8895% CI: [-22.81, 8.51]Regression, Linear
Secondary
Change From Baseline in Mean Triglycerides
Lipid profile was assessed after 12 hours of fasting.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Triglycerides | -2.21 mg/dL |
| Placebo | Change From Baseline in Mean Triglycerides | -12.44 mg/dL |
p-value: 0.6495% CI: [-34.61, 55.08]Regression, Linear
Other Pre-specified
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
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean 25-hydroxyvitamin D | 45.63 ng/mL |
| Placebo | Change From Baseline in Mean 25-hydroxyvitamin D | 1.32 ng/mL |
p-value: <0.00195% CI: [27.13, 61.48]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH) | -24.28 pg/mL |
| Placebo | Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH) | -16.45 pg/mL |
p-value: 0.4695% CI: [-29.34, 13.67]Regression, Linear
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.
Time frame: Baseline and 12 weeks
Population: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin D | Change From Baseline in Mean Vitamin D Binding Protein | 1.01 mg/dL |
| Placebo | Change From Baseline in Mean Vitamin D Binding Protein | -0.55 mg/dL |
p-value: 0.3895% CI: [-2.08, 5.2]Regression, Linear