AsthmaVDORA1NCT03686150
Vitamin D Oral Replacement in Asthma
A study testing Vitamin D3 oral regimen in people with Asthma and Vitamin D Deficiency, run by IDeA States Pediatric Clinical Trials Network at 15 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma, Vitamin D Deficiency, Pediatric Obesity
- What is being tested?
- Vitamin D3 oral regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 15 sitesUnited States
- Study dates
- 30 Jan 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
University of Vermont Medical Center
Burlington, Vermont, 05401
University of South Carolina
Columbia, South Carolina, 29208
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Children's Mercy Hospital
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
University of Louisville
Louisville, Kentucky, 40292
Dartmouth Hospital - Manchester
Manchester, New Hampshire, 03104
Community Medical Center
Missoula, Montana, 59804
West Virginia University
Morgantown, West Virginia, 26506
Children's Hospital OU Medical Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center/Children's Hospital and Medical Center
Omaha, Nebraska, 68198
Nemours/Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
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
- Asthma, Vitamin D Deficiency, Pediatric Obesity
- Being tested
- Vitamin D3 oral regimen
- Keywords
- pediatric obesity
- Medical subject headings
- Asthma, Vitamin D Deficiency, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 oral regimenDietary supplement
Vitamin D3 oral regimens supplementation
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Cohort 1 Vitamin D3 oral regimen | Experimental | Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose Receives: Dietary Supplement: Vitamin D3 oral regimen |
| Part 1, Cohort 2 Vitamin D3 oral regimen | Experimental | Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose Receives: Dietary Supplement: Vitamin D3 oral regimen |
| Part 1, Cohort 3 Vitamin D3 oral regimen | Experimental | Vitamin D: 6000 IU daily dose Receives: Dietary Supplement: Vitamin D3 oral regimen |
| Part 1, Cohort 4 Vitamin D3 oral regimen | Active comparator | Vitamin D: 600 IU daily dose Receives: Dietary Supplement: Vitamin D3 oral regimen |
| Part 2, Cohort A Vitamin D3 oral regimen | Experimental | Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD Receives: Dietary Supplement: Vitamin D3 oral regimen |
| Part 2, Cohort B Vitamin D oral regimen | Active comparator | Vitamin D: 600 IU daily dose Receives: Dietary Supplement: Vitamin D3 oral regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start30 Jan 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDeA States Pediatric Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686150
- Sponsor's protocol ID
- 101
- Other IDs
- U24OD024957
- Acronym
- VDORA1
- Status last verified
- Mar 2023
- First submitted
- 25 Sep 2018
- Last updated
- 19 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded to Data and Specimen Hub (DASH) of NICHD
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 32930511Lang JE, Ramirez RG, Balevic S, Bickel S, Hornik CP, Majure JM, Venkatachalam S, Snowden J, O'Sullivan B, James L. Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma. Clin Pharmacokinet. 2023 Nov;62(11):1567-1579. doi: 10.1007/s40262-023-01285-9. Epub 2023 Aug 30.
PubMed 37646988
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Oral Replacement in Asthma
- ClinicalTrials.gov ID
- NCT03686150
- Acronym / sponsor ID
- VDORA1 / 101
- Conditions
- Asthma, Vitamin D Deficiency, Pediatric Obesity
- Keywords
- pediatric obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- IDeA States Pediatric Clinical Trials NetworkResearch network
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Posted 19 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
| Arm | Type | Receives |
|---|---|---|
| Part 1, Cohort 1 Vitamin D3 oral regimen | Experimental | Dietary Supplement: Vitamin D3 oral regimenIntervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose |
| Part 1, Cohort 2 Vitamin D3 oral regimen | Experimental | Dietary Supplement: Vitamin D3 oral regimenVitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose |
| Part 1, Cohort 3 Vitamin D3 oral regimen | Experimental | Dietary Supplement: Vitamin D3 oral regimenVitamin D: 6000 IU daily dose |
| Part 1, Cohort 4 Vitamin D3 oral regimen | Active comparator | Dietary Supplement: Vitamin D3 oral regimenVitamin D: 600 IU daily dose |
| Part 2, Cohort A Vitamin D3 oral regimen | Experimental | Dietary Supplement: Vitamin D3 oral regimenVitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD |
| Part 2, Cohort B Vitamin D oral regimen | Active comparator | Dietary Supplement: Vitamin D3 oral regimenVitamin D: 600 IU daily dose |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 oral regimenVitamin D3 oral regimens supplementation | Dietary supplement | 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 |
Primary outcome
Part 1: Optimal Dosing Level to Use in Part 2
Time frame: 20 weeks
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.
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
Time frame: 16 weeks
Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32930511O'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.
- Derived from this study: PubMed 37646988Lang JE, Ramirez RG, Balevic S, Bickel S, Hornik CP, Majure JM, Venkatachalam S, Snowden J, O'Sullivan B, James L. Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma. Clin Pharmacokinet. 2023 Nov;62(11):1567-1579. doi: 10.1007/s40262-023-01285-9. Epub 2023 Aug 30.
- Individual participant dataSharing planned: Yes. Data will be uploaded to Data and Specimen Hub (DASH) of NICHD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 oral regimen in people with Asthma and Vitamin D Deficiency, run by IDeA States Pediatric Clinical Trials Network at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Optimal Dosing Level to Use in Part 2 (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03686150, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023; AzTrials last refreshed its copy on 26 Oct 2026.