Vitamin D Oral Replacement in Asthma

Study Overview
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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.

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.

Official Title
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Vitamin D Oral Replacement in Asthma

Conditions
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Asthma, Vitamin D Deficiency, Pediatric Obesity

Intervention / Treatment
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* Dietary Supplement: Vitamin D3 oral regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index greater than or equal to 85% for age and sex Physician-diagnosed asthma Ongoing relationship with asthma provider responsible for asthma care Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test Ability to swallow pills similar in size to the vitamin D preparation to be used Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate) Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method Child and parent, legal guardian, or caregiver must speak English or Spanish Exclusion Criteria: Known diseases of calcium metabolism or the parathyroid History of renal insufficiency or kidney stones Known liver failure or history of abnormal liver function tests History of Williams syndrome, sarcoidosis, or granulomatous disease Active tuberculosis Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration Clinical evidence of rickets Taking supplemental vitamin D greater than equal to 1000 IU per day

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, Cohort 1 Vitamin D3 oral regimen<br>Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose | Dietary Supplement: Vitamin D3 oral regimen<br>* Vitamin D3 oral regimens supplementation<br>|
| Experimental: Part 1, Cohort 2 Vitamin D3 oral regimen<br>Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose | Dietary Supplement: Vitamin D3 oral regimen<br>* Vitamin D3 oral regimens supplementation<br>|
| Experimental: Part 1, Cohort 3 Vitamin D3 oral regimen<br>Vitamin D: 6000 IU daily dose | Dietary Supplement: Vitamin D3 oral regimen<br>* Vitamin D3 oral regimens supplementation<br>|
| Active Comparator: Part 1, Cohort 4 Vitamin D3 oral regimen<br>Vitamin D: 600 IU daily dose | Dietary Supplement: Vitamin D3 oral regimen<br>* Vitamin D3 oral regimens supplementation<br>|
| Experimental: Part 2, Cohort A Vitamin D3 oral regimen<br>Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD | Dietary Supplement: Vitamin D3 oral regimen<br>* Vitamin D3 oral regimens supplementation<br>|
| Active Comparator: Part 2, Cohort B Vitamin D oral regimen<br>Vitamin D: 600 IU daily dose | Dietary Supplement: Vitamin D3 oral regimen<br>* Vitamin D3 oral regimens supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Optimal Dosing Level to Use in Part 2 | Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics. | 20 weeks | 
| Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml | Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric obesity