Trial Outcomes & Findings for Vitamin D and Severe Asthma Exacerbations (NCT NCT01921894)
NCT ID: NCT01921894
Last Updated: 2017-03-23
Results Overview
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
COMPLETED
PHASE1
48 participants
8 weeks
2017-03-23
Participant Flow
Subjects were enrolled from: 1) the Emergency Department of Children's Hospital of Pittsburgh (CHP), 2) the Pulmonary Medicine and Allergy clinics of CHP, 3) the General Pediatric Clinics of CHP, and 4) participants in a prior study of the Pediatric Environmental Medicine Center of CHP (who had consented to be contacted about studies of asthma).
We recruited 48 children who met initial inclusion/exclusion criteria. Of these 48 children, 20 were excluded because of a 25(OH)D ≥30 ng/ml (n=13) or lack of bronchodilator response or airway responsiveness (n=7) at visit 1. Of the 28 remaining children, 4 were excluded because of non-adherence or poor asthma control during the run-in period.
Participant milestones
| Measure |
Cholecalciferol 4000 IU
Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
|
Cholecalciferol 2000 IU
Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
|
Cholecalciferol 200 IU
Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D and Severe Asthma Exacerbations
Baseline characteristics by cohort
| Measure |
Cholecalciferol 4000 IU
n=8 Participants
Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
|
Cholecalciferol 2000 IU
n=8 Participants
Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
|
Cholecalciferol 200 IU
n=8 Participants
Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
9 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
2 participants
n=206 Participants
|
14 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Others
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=157 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
24 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: In this pilot study, we wanted to report and compare the proportion of subjects who achieved vitamin D sufficiency after 8 weeks of treatment with one of three vitamin D doses.
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Outcome measures
| Measure |
Cholecalciferol 4000 IU
n=8 Participants
All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 2000 IU
n=8 Participants
All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 200 IU
n=8 Participants
All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
|---|---|---|---|
|
Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation
|
8 participants
|
6 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The characteristics of the study population are the same as described for the other primary outcome (vitamin D sufficiency at 8 weeks)
The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Outcome measures
| Measure |
Cholecalciferol 4000 IU
n=8 Participants
All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 2000 IU
n=8 Participants
All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 200 IU
n=8 Participants
All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
|---|---|---|---|
|
Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation
|
6 participants
|
7 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: We wanted to report and compare the proportion of subjects who had vitamin D toxicity, hypercalcemia or an elevated UCa/UCr ratio across the three treatment arms
Participants with vitamin D toxicity, hypercalcemia (\>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (\>0.37)
Outcome measures
| Measure |
Cholecalciferol 4000 IU
n=8 Participants
All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 2000 IU
n=8 Participants
All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 200 IU
n=8 Participants
All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
|---|---|---|---|
|
Number of Participants With Vitamin D Toxicity
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4 and/or 8 weeksPopulation: We wanted to compare the proportion of subjects who had an elevated UCa/UCr ratio across the three groups in this pilot Phase I Study
Elevated urinary calcium/creatinine ratio defined as UCa/UCr \> 0.37 after either 4 weeks or 8 weeks of supplementation
Outcome measures
| Measure |
Cholecalciferol 4000 IU
n=8 Participants
All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 2000 IU
n=8 Participants
All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 200 IU
n=8 Participants
All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
|---|---|---|---|
|
Number of Participants With Elevated Urinary Calcium/Creatinine Ratio
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: We wanted to compare the proportion of subjects whose FEV1 % predicted fell below 80% predicted across the three arms in this pilot Phase I study.
Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).
Outcome measures
| Measure |
Cholecalciferol 4000 IU
n=8 Participants
All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 2000 IU
n=8 Participants
All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
Cholecalciferol 200 IU
n=8 Participants
All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
|
|---|---|---|---|
|
Number of Participants With FEV1 < 80% of Predicted
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Cholecalciferol 4000 IU
Cholecalciferol 2000 IU
Cholecalciferol 200 IU
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Juan C. Celedon, Niels K. Jerne Professor of Pediatrics
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place