VDORA1: Vitamin D Oral Replacement in Asthma

Sponsor

IDeA States Pediatric Clinical Trials Network (Other)

Overall Status

Completed

CT.gov ID

NCT03686150

Collaborator

(none)

166

Enrollment

Locations

Arms

Actual Duration (Months)

11.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Vitamin D Deficiency Pediatric Obesity	Dietary Supplement: Vitamin D3 oral regimen	N/A

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Vitamin D Oral Replacement in Asthma

Actual Study Start Date :

Jan 30, 2019

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Best dosing level of vitamin D supplementation [20 weeks]
Determine the best vitamin D supplementation level based on PK analysis
Part 1: optimal dosing level to use in part 2 [20 weeks]
Based on part 1 data, determine the best vitamin D supplementation level based on PK analysis
Part 2: Proportion of participants with vitamin D levels >= 40 ng/ml [16 weeks]
Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
2	Nemours/Alfred I duPont Hospital for Children	Wilmington	Delaware	United States	19803
3	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
4	University of Louisville	Louisville	Kentucky	United States	40292
5	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808
6	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
7	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
8	Community Medical Center	Missoula	Montana	United States	59804
9	University of Nebraska Medical Center/Children's Hospital and Medical Center	Omaha	Nebraska	United States	68198
10	Dartmouth Hospital - Manchester	Manchester	New Hampshire	United States	03104
11	University of New Mexico Health Sciences Center	Albuquerque	New Mexico	United States	87131
12	Children's Hospital OU Medical Center	Oklahoma City	Oklahoma	United States	73104
13	University of South Carolina	Columbia	South Carolina	United States	29208
14	University of Vermont Medical Center	Burlington	Vermont	United States	05401
15	West Virginia University	Morgantown	West Virginia	United States	26506