A Phase 1 interventional study of Cholecalciferol in Asthma, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2017-03-23.
Sponsored by University of Pittsburgh · Phase 1, Interventional, and Prevention
This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day.
In children with vitamin D insufficiency or deficiency who are at risk for severe asthma exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000 IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day) will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.
Asthma is a major public health problem in the United States and worldwide. Severe disease exacerbations account for the majority of costs attributable to asthma in the United States. Vitamin D is an essential nutrient with significant immuno-modulatory effects. The observation that vitamin D insufficiency and asthma share risk factors such as urban residence, obesity, and African American ethnicity has generated significant interest in exploring a link between these two conditions.
This is an 8-week randomized, double-masked, controlled trial of vitamin D3 (2,000 IU/day and 4,000 IU/day) to achieve vitamin D sufficiency (a serum 25(OH)D ≥30 ng/ml in 60 school-aged children (ages 6 to 14 years) who have vitamin D insufficiency (a serum 25(OH)D \<30 ng/ml) and are at risk for severe asthma exacerbations, but whose asthma that is well-controlled on medium-dose inhaled corticosteroid (ICS) at the end of a 4-week run-in period.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 48 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
Dietary Supplement: Cholecalciferol
Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
Dietary Supplement: Cholecalciferol
Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
Dietary Supplement: Cholecalciferol
vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
Also known as: vitamin D3
Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Time frame: 8 weeks
Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation
The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
Time frame: 4 weeks
Number of Participants With Vitamin D Toxicity
Participants with vitamin D toxicity, hypercalcemia (\>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (\>0.37)
Time frame: 8 weeks
Number of Participants With Elevated Urinary Calcium/Creatinine Ratio
Elevated urinary calcium/creatinine ratio defined as UCa/UCr \> 0.37 after either 4 weeks or 8 weeks of supplementation
Time frame: 4 and/or 8 weeks
Number of Participants With FEV1 < 80% of Predicted
Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).
Time frame: 8 weeks
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).
| Milestone | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
| participants | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU |
|---|---|---|---|
| Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation | 8 | 6 | 4 |
Participants with vitamin D toxicity, hypercalcemia (\>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (\>0.37)
| participants | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU |
|---|---|---|---|
| Number of Participants With Vitamin D Toxicity | 0 | 0 | 0 |
Elevated urinary calcium/creatinine ratio defined as UCa/UCr \> 0.37 after either 4 weeks or 8 weeks of supplementation
| participants | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU |
|---|---|---|---|
| Number of Participants With Elevated Urinary Calcium/Creatinine Ratio | 0 | 0 | 0 |
Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).
| participants | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU |
|---|---|---|---|
| Number of Participants With FEV1 < 80% of Predicted | 0 | 0 | 0 |
The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation
| participants | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU |
|---|---|---|---|
| Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation | 6 | 7 | 4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cholecalciferol 4000 IU | — | 0/8 (0%) | 0/8 (0%) |
| Cholecalciferol 2000 IU | — | 0/8 (0%) | 0/8 (0%) |
| Cholecalciferol 200 IU | — | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU | Total |
|---|---|---|---|---|
| <=18 years | 8 | 8 | 8 | 24 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU | Total |
|---|---|---|---|---|
| Female | 4 | 5 | 2 | 11 |
| Male | 4 | 3 | 6 | 13 |
| Race/Ethnicity, Customized(participants) | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU | Total |
|---|---|---|---|---|
| Non-Hispanic white | 2 | 2 | 5 | 9 |
| Non-Hispanic Black | 6 | 6 | 2 | 14 |
| Hispanic/Others | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Cholecalciferol 4000 IU | Cholecalciferol 2000 IU | Cholecalciferol 200 IU | Total |
|---|---|---|---|---|
| United States | 8 | 8 | 8 | 24 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pittsburgh