Trial Outcomes & Findings for Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents (NCT NCT01217840)
NCT ID: NCT01217840
Last Updated: 2017-11-29
Results Overview
Primary outcome is serum 25OH vitamin D concentrations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline; Week 24
Results posted on
2017-11-29
Participant Flow
Participant milestones
| Measure |
Vitamin D
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents
Baseline characteristics by cohort
| Measure |
Vitamin D
n=20 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=20 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.1 years
n=5 Participants
|
13.6 years
n=7 Participants
|
14.35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
BMI
|
36 kg/m^2
n=5 Participants
|
31 kg/m^2
n=7 Participants
|
33.22 kg/m^2
n=5 Participants
|
|
25OH vitamin D
|
19.4 ng/mL
n=5 Participants
|
24.2 ng/mL
n=7 Participants
|
21.8 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Primary outcome is serum 25OH vitamin D concentrations
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
25OH Vitamin D
Baseline
|
19.6 ng/mL
Standard Error 1.4
|
25.8 ng/mL
Standard Error 2.6
|
|
25OH Vitamin D
Week 24
|
20.1 ng/mL
Standard Error 0.9
|
24.6 ng/mL
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Triglycerides at Baseline and Week 24
Baseline
|
106 mg/dL
Standard Error 20
|
99 mg/dL
Standard Error 13
|
|
Triglycerides at Baseline and Week 24
Week 24
|
114 mg/dL
Standard Error 19
|
99 mg/dL
Standard Error 11
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
High-density Lipoprotein (HDL) at Baseline and Week 24
Baseline
|
41 mg/dL
Standard Error 3
|
46 mg/dL
Standard Error 3
|
|
High-density Lipoprotein (HDL) at Baseline and Week 24
Week 24
|
41 mg/dL
Standard Error 2
|
47 mg/dL
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Hemoglobin A1C (HgbA1c) at Baseline and Week 24
Baseline
|
5.4 Percentage of glycosylated hemoglobin
Standard Error 0.1
|
5.3 Percentage of glycosylated hemoglobin
Standard Error 0.1
|
|
Hemoglobin A1C (HgbA1c) at Baseline and Week 24
Week 24
|
5.4 Percentage of glycosylated hemoglobin
Standard Error 0.1
|
5.3 Percentage of glycosylated hemoglobin
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Interleukin-6 (IL-6) at Baseline and Week 24
Baseline
|
1.0 pg/mL
Interval 0.6 to 1.3
|
0.7 pg/mL
Interval 0.4 to 1.3
|
|
Interleukin-6 (IL-6) at Baseline and Week 24
Week 24
|
1.0 pg/mL
Interval 0.7 to 1.7
|
0.7 pg/mL
Interval 0.4 to 1.2
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Interleukin-10 (IL-10) at Baseline and Week 24
Baseline
|
1.7 pg/mL
Interval 0.8 to 2.2
|
2.0 pg/mL
Interval 0.8 to 4.6
|
|
Interleukin-10 (IL-10) at Baseline and Week 24
Week 24
|
1.7 pg/mL
Interval 0.7 to 4.1
|
2.3 pg/mL
Interval 1.2 to 4.6
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
Baseline
|
6.0 pg/mL
Interval 4.9 to 8.7
|
7.2 pg/mL
Interval 6.4 to 7.7
|
|
Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
Week 24
|
6.9 pg/mL
Interval 5.5 to 8.0
|
7.5 pg/mL
Interval 6.5 to 8.2
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
C-reactive Protein (CRP) at Baseline and Week 24
Baseline
|
4.0 mg/L
Standard Error 1.0
|
2.2 mg/L
Standard Error 0.5
|
|
C-reactive Protein (CRP) at Baseline and Week 24
Week 24
|
4.3 mg/L
Standard Error 0.9
|
2.3 mg/L
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Patients who completed the study were analyzed.
Outcome measures
| Measure |
Vitamin D
n=14 Participants
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=17 Participants
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Adiponectin at Baseline and Week 24
Baseline
|
4.8 pg/mL
Interval 3.4 to 6.7
|
7.2 pg/mL
Interval 3.6 to 8.8
|
|
Adiponectin at Baseline and Week 24
Week 24
|
5.9 pg/mL
Interval 3.6 to 8.9
|
7.3 pg/mL
Interval 4.3 to 11.2
|
Adverse Events
Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D
n=20 participants at risk
Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
|
Placebo
n=20 participants at risk
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks
|
|---|---|---|
|
Endocrine disorders
Hypercalcemia
|
0.00%
0/20 • 24 weeks
|
5.0%
1/20 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place