Official Title
Vitamin D Oral Replacement in Asthma
Phase
Phase 1Lead Sponsor
IDeA States Pediatric Clinical Trials NetworkStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Asthma Vitamin D Deficiency Pediatric ObesityIntervention/Treatment
Vitamin D3 oral regimenStudy Participants
112The 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.
Vitamin D3 oral regimens supplementation
Vitamin D: 6000 IU daily dose
Vitamin D: 600 IU daily dose
Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
Vitamin D: 600 IU daily dose
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
| Event Type | Organ System | Event Term | Part 1, Cohort 1 Vitamin D3 Oral Regimen | Part 1, Cohort 2 Vitamin D3 Oral Regimen | Part 1, Cohort 3 Vitamin D3 Oral Regimen | Part 1, Cohort 4 Vitamin D3 Oral Regimen | Part 2, Cohort A Vitamin D3 Oral Regimen | Part 2, Cohort B Vitamin D Oral Regimen |
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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.
Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml
