Phase 1
Completed N=24
Vitamin D and Severe Asthma Exacerbations
Source: ClinicalTrials.gov NCT01921894 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation — 8; 6; 4 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation |
8; 6; 4 | — |
| PRIMARY Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation |
6; 7; 4 | — |
| SECONDARY Number of Participants With Vitamin D Toxicity |
0; 0; 0 | — |
| SECONDARY Number of Participants With Elevated Urinary Calcium/Creatinine Ratio |
0; 0; 0 | — |
| SECONDARY Number of Participants With FEV1 < 80% of Predicted |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Be at least 6 years of age and younger than 15 years of age
- Have physician-diagnosed asthma
- Taking a medium dose of ICS (e.g. fluticasone 220mcg BID) for daily asthma control for at least 6 months in the prior year.
- Have had a severe asthma exacerbation in the previous year, defined as an Emergency Department (ED) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.
- Have bronchodilator responsiveness (BDR, an increase in FEV1 ≥12% from baseline after administration of inhaled albuterol) or (if no BDR) increased airway responsiveness to methacholine challenge
- Have vitamin D insufficiency (a serum vitamin D (25(OH)D) level 10.8 mg/dl
- Serum 25(OH) D <10 ng/ml (severe vitamin D deficiency)
Data sourced from ClinicalTrials.gov (NCT01921894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.