NCT03686150

Vitamin D Oral Replacement in Asthma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: IDeA States Pediatric Clinical Trials Network · Network
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Asthma
• Vitamin D Deficiency
• Pediatric Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3 oral regimen	Vitamin D3 oral regimens supplementation

Timeline

• Start date: 2019-01-30
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2018-09-26
• Last updated: 2023-04-19
• Results posted: 2023-04-19

Locations

15 sites across 1 country: United States