Vitamin D Oral Replacement in Asthma (VDORA1)
Questions
Questions about ECHO's involvement in the VDORA1 Study can be directed to the Program Office.
Study Summary:
The overall objective of the study is to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.
This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.
In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period.
Across both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.
List of VDORA1 Sites and Funded Institutions
Additional information for the participating sites can be found here.
| AR | Arkansas |
| DE | Delaware |
| HI | Hawaii |
| KS | Kansas |
| KY | Kentucky |
| LA | Louisiana |
| MS | Mississippi |
| MT | Montana |
| NE | Nebraska |
| NH | New Hampshire |
| NM | New Mexico |
| OK | Oklahoma |
| SC | South Carolina |
| VT | Vermont |
| WV | West Virginia |
Protocol Chairs
Brian O'Sullivan, MD
J. Marc Majure, MD
Laura James, MD, FAAP
