CompletedNCT03686150VDORA1Updated Apr 19, 2023Results posted

Vitamin D Oral Replacement in Asthma

An interventional study of Vitamin D3 oral regimen in Asthma, Vitamin D Deficiency and Pediatric Obesity, sponsored by IDeA States Pediatric Clinical Trials Network. Completed at 15 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by IDeA States Pediatric Clinical Trials Network · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 112
Allocation: Randomized
Ages: 6 Years to 17 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Asthma
Vitamin D Deficiency
Pediatric Obesity

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Keywords

pediatric obesity

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 112 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

IDeA States Pediatric Clinical Trials Network is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 112 participants (actual)

Study arms

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
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
Experimental
Part 1, Cohort 3 Vitamin D3 oral regimen
Vitamin D: 6000 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
Active comparator
Part 1, Cohort 4 Vitamin D3 oral regimen
Vitamin D: 600 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
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
Active comparator
Part 2, Cohort B Vitamin D oral regimen
Vitamin D: 600 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen

Interventions

Dietary supplementVitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

What researchers measure

Primary outcomes

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.
Time frame: 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
Time frame: 16 weeks

Results

Posted Apr 19, 2023

Participant flow

A total of 166 study participants consented to be screened for the trial; 112 met eligibility criteria and were randomized onto the trial. The trial comprised of a Dose Finding part (Part 1) and a Dose Confirming par (Part 2). During Part 1, participants (children) were enrolled and randomized to one of four dose groups at 1:1:1:1 allocation ratio. During Part 2, participants (children) were randomized to one of two dose groups at 2:1 allocation ratio.

Participant flow — Overall Study
Milestone	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
Started	13	12	11	12	43	21
Completed	11	10	10	12	42	18
Not completed	2	2	1	0	1	3
Withdrew: Withdrawal by subject	1	1	1	0	1	2
Withdrew: Physician decision	1	0	0	0	0	1
Withdrew: Lost to follow-up	0	1	0	0	0	0

Outcome measures

PrimaryPart 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.

Time frame:: 20 weeks
Reported as:: Number · IU

Part 1: Optimal Dosing Level to Use in Part 2
IU	Vitamin D3 Oral Regimen
Daily Dose (IU)	8000
Single Loading Dose (IU)	50000

Statistical analysis

Vitamin D3 Oral Regimen ·

PrimaryPart 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml

Proportion of participants in part 2 who achieve vitamin levels \>= 40 ng/ml

Time frame:: 16 weeks
Reported as:: Number · proportion of participants

Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
proportion of participants	Part 2, Cohort A Vitamin D3 Oral Regimen	Part 2, Cohort B Vitamin D Oral Regimen
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml	0.786 (0.641 to 0.883)	0 (0 to 0.176)

Statistical analysis

Part 2, Cohort A Vitamin D3 Oral Regimen · z-test · p = 0.0001

Adverse events

Collected over Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1, Cohort 1 Vitamin D3 Oral Regimen	0/13 (0%)	0/13 (0%)	11/13 (84.6%)
Part 1, Cohort 2 Vitamin D3 Oral Regimen	0/12 (0%)	1/12 (8.3%)	9/12 (75%)
Part 1, Cohort 3 Vitamin D3 Oral Regimen	0/11 (0%)	1/11 (9.1%)	11/11 (100%)
Part 1, Cohort 4 Vitamin D3 Oral Regimen	0/12 (0%)	1/12 (8.3%)	10/12 (83.3%)
Part 2, Cohort A Vitamin D3 Oral Regimen	0/43 (0%)	0/43 (0%)	21/43 (48.8%)
Part 2, Cohort B Vitamin D Oral Regimen	0/21 (0%)	1/21 (4.8%)	14/21 (66.7%)

Most frequent serious events

Most frequent serious events
Event	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
AsthmaRespiratory, thoracic and mediastinal disorders	0/13	1/12	1/11	1/12	0/43	0/21
Anaphylactic ReactionImmune system disorders	0/13	0/12	0/11	0/12	0/43	1/21

Most frequent other events

Showing 10 of 120

Most frequent other events
Event	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
asthmaRespiratory, thoracic and mediastinal disorders	4/13	3/12	5/11	3/12	1/43	3/21
coughRespiratory, thoracic and mediastinal disorders	4/13	4/12	5/11	3/12	2/43	2/21
nasal congestionRespiratory, thoracic and mediastinal disorders	2/13	1/12	4/11	1/12	1/43	1/21
headacheNervous system disorders	0/13	3/12	3/11	2/12	3/43	1/21
rashSkin and subcutaneous tissue disorders	0/13	2/12	3/11	1/12	2/43	0/21
pyrexiaGeneral disorders	0/13	0/12	0/11	3/12	0/43	1/21
upper respiratory tract infectionInfections and infestations	1/13	3/12	0/11	0/12	0/43	1/21
oropharyngeal painGastrointestinal disorders	0/13	0/12	2/11	1/12	0/43	0/21
wheezingRespiratory, thoracic and mediastinal disorders	2/13	1/12	2/11	1/12	1/43	1/21
ear infectionInfections and infestations	0/13	2/12	0/11	1/12	1/43	0/21

Baseline characteristics

This vitamin D supplementation study was performed in two parts: 1) PK analysis to identify recommended dost for part 2, and 2) assess the effectiveness of the recommended 16-week dosing regimen to achieve serum level of 25(OH)D greater than or equal to 40 ng/mL.

Age, Continuous
Age, Continuous(years)	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	Total
Mean	12.8 ± 3.1	12.3 ± 3.4	11.5 ± 3.6	12.5 ± 2.9	12.2 ± 2.5	11.7 ± 2.6	12.1 ± 2.8

Sex: Female, Male
Sex: Female, Male(Participants)	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	Total
Female	6	7	5	5	20	10	53
Male	7	5	6	7	23	11	59

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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	Total
Hispanic or Latino	5	2	2	1	7	3	20
Not Hispanic or Latino	7	10	8	10	33	18	86
Unknown or Not Reported	1	0	1	1	3	0	6

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	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	Total
American Indian or Alaska Native	0	0	0	0	3	1	4
Asian	0	1	1	0	0	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	1	0	1
Black or African American	6	4	5	6	15	9	45
White	4	5	3	5	19	10	46
More than one race	0	1	1	1	2	1	6
Unknown or Not Reported	3	1	1	0	3	0	8

Baseline Body Mass Index (BMI)
Baseline Body Mass Index (BMI)(kg/m^2)	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	Total
Mean	33.9 ± 8.4	29.7 ± 6.4	30.1 ± 4.3	32.2 ± 9.2	30.8 ± 6.9	30.3 ± 8.2	31.0 ± 7.3

BMI percentile
BMI percentile(Participants)	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	Total
>= 85th to < 95th	3	2	2	3	9	5	24
>= 95th to < 99th	4	3	2	3	16	8	36
>= 99th	6	7	7	6	18	8	52

Rural-Urban Commuting Area (RUCA) codes
Rural-Urban Commuting Area (RUCA) codes(Participants)	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	Total
Metropolitan	13	10	9	11	32	17	92
Micropolitan	0	1	1	0	5	1	8
Small town	0	1	1	1	3	2	8
Rural	0	0	0	0	3	1	4

Baseline 25(OH)D
Baseline 25(OH)D(ng/mL)	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	Total
Mean	18.3 ± 6.5	20.8 ± 7.2	19.0 ± 5.2	17.6 ± 5.8	17.7 ± 6.0	16.3 ± 5.2	18.0 ± 6.0

1 further baseline measures are reported on the registry.

Study locations

15 sites

Arkansas Children's Hospital
Little Rock, Arkansas 72202, United States
Nemours/Alfred I duPont Hospital for Children
Wilmington, Delaware 19803, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826, United States
University of Louisville
Louisville, Kentucky 40292, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808, United States
University of Mississippi Medical Center
Jackson, Mississippi 39216, United States
Children's Mercy Hospital
Kansas City, Missouri 64108, United States
Community Medical Center
Missoula, Montana 59804, United States
University of Nebraska Medical Center/Children's Hospital and Medical Center
Omaha, Nebraska 68198, United States
Dartmouth Hospital - Manchester
Manchester, New Hampshire 03104, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87131, United States
Children's Hospital OU Medical Center
Oklahoma City, Oklahoma 73104, United States
University of South Carolina
Columbia, South Carolina 29208, United States
University of Vermont Medical Center
Burlington, Vermont 05401, United States
West Virginia University
Morgantown, West Virginia 26506, United States

References and documents

Publications

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. PubMed 32930511 ↗

Study documents

Protocol and statistical analysis plan · Dec 14, 2020
Informed consent form · Nov 2, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data will be uploaded to Data and Specimen Hub (DASH) of NICHD

Supporting information: Study protocol, Icf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03686150
Lead sponsor: IDeA States Pediatric Clinical Trials Network
Collaborators: National Institutes of Health (NIH)
Responsible party: Sponsor
First posted: Sep 26, 2018
Start date: Jan 30, 2019
Primary completion: Sep 30, 2021
Completion: Sep 30, 2021
Results posted: Apr 19, 2023
Last update: Apr 19, 2023

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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