Trial Outcomes & Findings for Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS) (NCT NCT00907153)
NCT ID: NCT00907153
Last Updated: 2017-12-19
Results Overview
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/\[log(I(0)) + log(G(0))\]).
COMPLETED
PHASE1/PHASE2
36 participants
Baseline and 12 weeks
2017-12-19
Participant Flow
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.
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.
Participant milestones
| Measure |
Vitamin D
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Vitamin D
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Baseline characteristics by cohort
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
37.20 kg/m2
STANDARD_DEVIATION 4.53 • n=5 Participants
|
35.09 kg/m2
STANDARD_DEVIATION 9.81 • n=7 Participants
|
36.1 kg/m2
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Systolic blood pressure
|
117.46 mm Hg
STANDARD_DEVIATION 10.00 • n=5 Participants
|
113.91 mm Hg
STANDARD_DEVIATION 10.21 • n=7 Participants
|
115.56 mm Hg
STANDARD_DEVIATION 10.11 • n=5 Participants
|
|
Diastolic blood pressure
|
79.08 mm hg
STANDARD_DEVIATION 8.28 • n=5 Participants
|
74.88 mm hg
STANDARD_DEVIATION 7.72 • n=7 Participants
|
76.83 mm hg
STANDARD_DEVIATION 7.98 • n=5 Participants
|
|
25-hydroxyvitamin D
|
19.95 ng/mL
STANDARD_DEVIATION 9.47 • n=5 Participants
|
22.20 ng/mL
STANDARD_DEVIATION 6.86 • n=7 Participants
|
21.15 ng/mL
STANDARD_DEVIATION 8.10 • n=5 Participants
|
|
Vitamin D binding protein
|
30.46 mg/dL
STANDARD_DEVIATION 8.53 • n=5 Participants
|
31.95 mg/dL
STANDARD_DEVIATION 7.54 • n=7 Participants
|
31.34 mg/dL
STANDARD_DEVIATION 8.04 • n=5 Participants
|
|
Intact parathyroid hormone (i-PTH)
|
40.81 pg/mL
STANDARD_DEVIATION 27.34 • n=5 Participants
|
33.17 pg/mL
STANDARD_DEVIATION 17.73 • n=7 Participants
|
36.72 pg/mL
STANDARD_DEVIATION 22.19 • n=5 Participants
|
|
Fasting glucose
|
84.92 mg/dL
STANDARD_DEVIATION 9.46 • n=5 Participants
|
83.73 mg/dL
STANDARD_DEVIATION 9.33 • n=7 Participants
|
84.29 mg/dL
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
Fasting insulin
|
26.31 uU/mL
STANDARD_DEVIATION 9.60 • n=5 Participants
|
27.13 uU/mL
STANDARD_DEVIATION 15.79 • n=7 Participants
|
26.75 uU/mL
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
2-hour glucose
|
122.08 mg/dL
STANDARD_DEVIATION 36.29 • n=5 Participants
|
110.07 mg/dL
STANDARD_DEVIATION 23.68 • n=7 Participants
|
115.64 mg/dL
STANDARD_DEVIATION 30.22 • n=5 Participants
|
|
2-hour insulin
|
214.69 uU/mL
STANDARD_DEVIATION 146.41 • n=5 Participants
|
107.07 uU/mL
STANDARD_DEVIATION 55.20 • n=7 Participants
|
157.04 uU/mL
STANDARD_DEVIATION 118.72 • n=5 Participants
|
|
Insulin sensitivity index 0,120
|
55.55 mg·l^2/mmol·mU·min
STANDARD_DEVIATION 23.26 • n=5 Participants
|
63.56 mg·l^2/mmol·mU·min
STANDARD_DEVIATION 16.37 • n=7 Participants
|
59.84 mg·l^2/mmol·mU·min
STANDARD_DEVIATION 19.57 • n=5 Participants
|
|
Quantitative Insulin Sensitivity Check Index (QUICKI)
|
0.302 units on a scale
STANDARD_DEVIATION 0.014 • n=5 Participants
|
0.307 units on a scale
STANDARD_DEVIATION 0.029 • n=7 Participants
|
0.305 units on a scale
STANDARD_DEVIATION 0.022 • n=5 Participants
|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
|
5.47 units on a scale
STANDARD_DEVIATION 1.82 • n=5 Participants
|
5.80 units on a scale
STANDARD_DEVIATION 3.90 • n=7 Participants
|
5.65 units on a scale
STANDARD_DEVIATION 2.93 • n=5 Participants
|
|
Total cholesterol
|
172.00 mg/dL
STANDARD_DEVIATION 42.70 • n=5 Participants
|
184.27 mg/dL
STANDARD_DEVIATION 32.52 • n=7 Participants
|
178.57 mg/dL
STANDARD_DEVIATION 37.38 • n=5 Participants
|
|
HDL cholesterol
|
45.54 mg/dL
STANDARD_DEVIATION 17.60 • n=5 Participants
|
37.00 mg/dL
STANDARD_DEVIATION 10.83 • n=7 Participants
|
40.96 mg/dL
STANDARD_DEVIATION 14.74 • n=5 Participants
|
|
LDL cholesterol
|
98.62 mg/dL
STANDARD_DEVIATION 36.96 • n=5 Participants
|
117.33 mg/dL
STANDARD_DEVIATION 28.56 • n=7 Participants
|
108.64 mg/dL
STANDARD_DEVIATION 33.47 • n=5 Participants
|
|
Triglyecrides
|
139.08 mg/dL
STANDARD_DEVIATION 71.61 • n=5 Participants
|
149.47 mg/dL
STANDARD_DEVIATION 85.46 • n=7 Participants
|
144.64 mg/dL
STANDARD_DEVIATION 78.07 • n=5 Participants
|
|
High sensitive C-reactive protein (hsCRP)
|
7.95 mg/L
STANDARD_DEVIATION 5.24 • n=5 Participants
|
4.42 mg/L
STANDARD_DEVIATION 4.34 • n=7 Participants
|
6.1 mg/L
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Total testosterone
|
54.23 ng/dL
STANDARD_DEVIATION 28.16 • n=5 Participants
|
41.27 ng/dL
STANDARD_DEVIATION 17.29 • n=7 Participants
|
48.48 ng/dL
STANDARD_DEVIATION 23.03 • n=5 Participants
|
|
Free testosterone
|
19.08 ng/dL
STANDARD_DEVIATION 15.79 • n=5 Participants
|
14.00 ng/dL
STANDARD_DEVIATION 10.88 • n=7 Participants
|
16.89 ng/dL
STANDARD_DEVIATION 13.33 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
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/\[log(I(0)) + log(G(0))\]).
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
|
-0.008 units on a scale
Interval -0.02 to 0.004
|
0.009 units on a scale
Interval -0.003 to 0.021
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
|
0.90 mg/L
Interval -2.46 to 4.27
|
2.04 mg/L
Interval -1.37 to 5.45
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Systolic Blood Pressure
|
0.64 mm Hg
Interval -7.13 to 8.42
|
4.29 mm Hg
Interval -3.15 to 11.74
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Diastolic Blood Pressure
|
-0.91 mm Hg
Interval -4.96 to 3.14
|
5.60 mm Hg
Interval 1.69 to 9.52
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Glucose was assessed after 12 hours of fasting.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Fasting Glucose
|
-0.70 mg/dL
Interval -7.96 to 6.56
|
-6.98 mg/dL
Interval -14.31 to 0.34
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Insulin was assessed after 12 hours of fasting.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Fasting Insulin
|
13.04 uU/mL
Interval -3.96 to 30.05
|
-0.80 uU/mL
Interval -18.03 to 16.43
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
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).
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean 2-hour Glucose
|
-11.66 mg/dL
Interval -33.22 to 9.89
|
1.14 mg/dL
Interval -20.1 to 22.38
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
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).
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean 2-hour Insulin
|
-62.02 uU/mL
Interval -124.5 to 0.49
|
13.06 uU/mL
Interval -47.94 to 74.06
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
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).
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
|
6.67 mg·l^2/mmol·mU·min
Interval -16.87 to 30.21
|
5.94 mg·l^2/mmol·mU·min
Interval -17.77 to 29.65
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
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.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
|
2.57 units on a scale
Interval -0.9 to 6.03
|
-0.51 units on a scale
Interval -4.01 to 2.99
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Lipid profile was assessed after 12 hours of fasting.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Total Cholesterol
|
-1.69 mg/dL
Interval -19.04 to 15.66
|
-1.80 mg/dL
Interval -19.55 to 15.95
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Lipid profile was assessed after 12 hours of fasting.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean HDL Cholesterol
|
-0.70 mg/dL
Interval -6.52 to 5.12
|
1.23 mg/dL
Interval -4.68 to 7.14
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Lipid profile was assessed after 12 hours of fasting.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean LDL Cholesterol
|
-0.12 mg/dL
Interval -14.7 to 14.46
|
-0.40 mg/dL
Interval -15.24 to 14.45
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Lipid profile was assessed after 12 hours of fasting.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Triglycerides
|
-2.21 mg/dL
Interval -34.11 to 29.69
|
-12.44 mg/dL
Interval -44.68 to 19.8
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Total Testosterone
|
3.01 ng/dL
Interval -8.05 to 14.06
|
10.16 ng/dL
Interval -1.16 to 21.47
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Free Testosterone
|
2.67 ng/dL
Interval -1.29 to 6.63
|
5.82 ng/dL
Interval 1.82 to 9.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean 25-hydroxyvitamin D
|
45.63 ng/mL
Interval 33.5 to 57.76
|
1.32 ng/mL
Interval -10.93 to 13.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Vitamin D Binding Protein
|
1.01 mg/dL
Interval -1.6 to 3.62
|
-0.55 mg/dL
Interval -3.14 to 2.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksPopulation: All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.
Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
Outcome measures
| Measure |
Vitamin D
n=13 Participants
Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
|
Placebo
n=15 Participants
Placebo: Placebo by mouth once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)
|
-24.28 pg/mL
Interval -39.8 to -8.76
|
-16.45 pg/mL
Interval -31.4 to -1.49
|
Adverse Events
Vitamin D
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place