Trial Outcomes & Findings for Correction of Vitamin D Levels and Its Effect on Insulin Resistance and Weight Gain in Obese Youth (NCT NCT02168660)
NCT ID: NCT02168660
Last Updated: 2019-12-09
Results Overview
Change in HOMA-IR from initial visit to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached).
Results posted on
2019-12-09
Participant Flow
Participant milestones
| Measure |
Control Group
Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
Low-Normal Group
Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
High-Normal Group
Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
35
|
36
|
|
Overall Study
COMPLETED
|
22
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Correction of Vitamin D Levels and Its Effect on Insulin Resistance and Weight Gain in Obese Youth
Baseline characteristics by cohort
| Measure |
Control Group
n=22 Participants
Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
Low-Normal Group
n=18 Participants
Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
High-Normal Group
n=21 Participants
Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
12 years
n=5 Participants
|
12 years
n=7 Participants
|
13 years
n=5 Participants
|
12 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
21 participants
n=5 Participants
|
61 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached).Population: Beginning and ending anthropometric data were available within the specified time limits on 61 subjects and 25-hydroxyvitamin D3 (25-OHD) levels on 45. Corresponding insulin and glucose data (allowing calculation of HOMA-IR) were available on only 26 subjects, mainly because many 25-OHD levels were obtained when subjects were not fasting.
Change in HOMA-IR from initial visit to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405.
Outcome measures
| Measure |
Control Group
n=7 Participants
Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
Low-Normal Group
n=11 Participants
Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
High-Normal Group
n=8 Participants
Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
|---|---|---|---|
|
Change in HOMA-IR
|
0 HOMA-IR score
Interval -1.8 to 1.4
|
-1.5 HOMA-IR score
Interval -3.9 to 0.9
|
-1.7 HOMA-IR score
Interval -4.3 to -0.3
|
SECONDARY outcome
Timeframe: 1 to 12 monthsPopulation: Timing of sample collections was too irregular to permit analysis.
The time required to reach a normal Vitamin D level (\> 30) versus BMI Z score at each vitamin D3 dose; OR vitamin D level at 6 weeks versus BMI Z score at each starting vitamin D3 dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached).The change in BMI z-score from baseline to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population.
Outcome measures
| Measure |
Control Group
n=22 Participants
Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
Low-Normal Group
n=18 Participants
Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
High-Normal Group
n=21 Participants
Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
|---|---|---|---|
|
Change in BMI Z-score
|
0.03 z-score
Interval -0.04 to 0.07
|
-0.07 z-score
Interval -0.11 to -0.03
|
-0.03 z-score
Interval -0.12 to 0.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-Normal Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High-Normal Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=22 participants at risk
Standard vitamin D3 dose as per IOM (Institute of Medicine) recommendations; actual dose will be 5000 IU per week, which is just slightly higher than the IOM recommendation of 600 IU per day. Length of time proposed to be 4 months at 5000 IU D3 per week. End of study measures at 4 months to be HOMA-IR, BMI Z score, 25-OH D level.
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
Low-Normal Group
n=18 participants at risk
Initial D3 dose will be 30,000 IU per week; at 6 week intervals serum D3 levels will be checked, and dose adjustments made to reach target 25-OHD level of between 30-50 ng/mL (inclusive). Once within target, D3 dose will be continued for 4 months, and end of study measurements done (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
High-Normal Group
n=21 participants at risk
Initial D3 dose will be 60,000 IU/week; at 6 week intervals 25-OHD levels will be done, and dose adjustments made to achieve target level of 40-60 ng/mL (inclusive). Once within target range, De3 dose will be continued for 4 months, and end of study measures obtained (HOMA-IR, BMI Z score, 25-OHD level).
Vitamin D3: Vitamin D3, liquid formulation, 5000 IU/mL.
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/22
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
Additional Information
Dr Perrin C White, Professor of Pediatrics
UT Southwestern Medical Center
Phone: 2146486875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place