Clinical trial NCT03686150: Vitamin D Oral Replacement in Asthma
Official title: Vitamin D Oral Replacement in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Vitamin D Deficiency
Pediatric Obesity
Keywords: pediatric obesity
Lead sponsor: IDeA States Pediatric Clinical Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-09-26
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
Primary purpose: OTHER

Brief 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.

Eligibility 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

Primary outcomes:
measure: Part 1: Optimal Dosing Level to Use in Part 2
timeFrame: 20 weeks
measure: Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Wilmington
country: United States
facility: Nemours/Alfred I duPont Hospital for Children
state: Delaware
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Missoula
country: United States
facility: Community Medical Center
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center/Children's Hospital and Medical Center
state: Nebraska
city: Manchester
country: United States
facility: Dartmouth Hospital - Manchester
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Oklahoma City
country: United States
facility: Children's Hospital OU Medical Center
state: Oklahoma
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
citation: O'Sullivan BP, James L, Majure JM, Bickel S, Phan LT, Serrano Gonzalez M, Staples H, Tam-Williams J, Lang J, Snowden J; IDeA States Pediatric Clinical Trials Network. Obesity-related asthma in children: A role for vitamin D. Pediatr Pulmonol. 2021 Feb;56(2):354-361. doi: 10.1002/ppul.25053. Epub 2020 Dec 8.