Official Title

Vitamin D Oral Replacement in Asthma
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    166
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.
Study Started
Jan 30
2019
Primary Completion
Sep 30
2021
Study Completion
Sep 30
2021
Last Update
Apr 05
2022

Dietary Supplement Vitamin D3 oral regimen

Vitamin D3 oral regimens supplementation

Part 1, Cohort 1 Vitamin D3 oral regimen Experimental

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

Part 1, Cohort 2 Vitamin D3 oral regimen Experimental

Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose

Part 1, Cohort 3 Vitamin D3 oral regimen Experimental

Vitamin D: 6000 IU daily dose

Part 1, Cohort 4 Vitamin D3 oral regimen Active Comparator

Vitamin D: 600 IU daily dose

Part 2, Cohort A Vitamin D3 oral regimen Experimental

Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD

Part 2, Cohort B Vitamin D oral regimen Active Comparator

Vitamin D: 600 IU daily dose

Criteria

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
No Results Posted