Vitamin D Oral Replacement in Asthma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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

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Asthma Vitamin D Deficiency Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part 1, Cohort 1 Vitamin D3 oral regimen

Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose

Group Type EXPERIMENTAL