drugset / Trial / NCT02687815
Vitamin D to Prevent Severe Asthma Exacerbations (Vit-D-Kids Asthma)
Phase 2
Terminated
192 enrolled
Juan Celedon, MD
National Heart, Lung, and Blood Institute (NHLBI) · collabPharmavite LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will determine whether vitamin D3 prevents severe asthma attacks in children who have a serum vitamin D (25(OH)D) level \<30 ng/ml and who are being treated with inhaled corticosteroids for asthma. Half the participants will receive vitamin D3 at a dose of 4,000 IU/day, and the other half will receive placebo.
Timeline
- Start
- 2016-02-22
- Primary completion
- 2019-09-17
- Completion
- 2019-09-17
Outcome
Missed primary endpoint
Stopped: “Futility of vitamin D supplementation based on protocol threshold: \<30% conditional power to detect pre-specified effect- 16% reduction in severe exacerbations.”
registry analysis (superiority test); Vitamin D3 vs Placebo; p = 0.63; Hazard Ratio (HR) 1.13 (95% CI 0.69 to 1.85); Regression, Cox NCT02687815 ↗
Publications
- Han YY, Forno E, Bacharier LB, Phipatanakul W, Guilbert TW, Cabana MD, Ross K, Blatter J, Rosser FJ, Durrani S, Luther J, Wisniewski SR, Celedon JC. Vitamin D supplementation, lung function and asthma control in children with asthma and low vitamin D levels. Eur Respir J. 2021 Oct 28;58(4):2100989. doi: 10.1183/13993003.00989-2021. Print 2021 Oct.
- Forno E, Bacharier LB, Phipatanakul W, Guilbert TW, Cabana MD, Ross K, Covar R, Gern JE, Rosser FJ, Blatter J, Durrani S, Han YY, Wisniewski SR, Celedon JC. Effect of Vitamin D3 Supplementation on Severe Asthma Exacerbations in Children With Asthma and Low Vitamin D Levels: The VDKA Randomized Clinical Trial. JAMA. 2020 Aug 25;324(8):752-760. doi: 10.1001/jama.2020.12384.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 4000 iu | Oral |