NCT03686150 (VDORA1) is a NA clinical trial of Vitamin D3 oral regimen in Asthma, sponsored by IDeA States Pediatric Clinical Trials Network.

Who is sponsoring NCT03686150?

NCT03686150 is sponsored by IDeA States Pediatric Clinical Trials Network.

What drugs are being tested in NCT03686150?

Interventions in NCT03686150: Vitamin D3 oral regimen.

What condition does NCT03686150 study?

NCT03686150 studies Asthma, Vitamin D Deficiency, Pediatric Obesity.

Is NCT03686150 still recruiting?

NCT03686150 is currently completed. Last updated 19 April 2023.

Are results published for NCT03686150?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-04-19 · How we verify

NCT03686150: VDORA1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Vitamin D Oral Replacement in Asthma

Completed NA Results posted Last updated 19 April 2023

What this trial tests

NA trial testing Vitamin D3 oral regimen in Asthma in 112 participants. Completed in 30 September 2021.

Timeline

30 January 2019

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	IDeA States Pediatric Clinical Trials Network
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	112
Start date	30 January 2019
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	15 locations across United States

Drugs / interventions tested

Vitamin D3 oral regimen

Conditions studied

Asthma — all drugs for Asthma →
Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
Pediatric Obesity — all drugs for Pediatric Obesity →

Sponsor

IDeA States Pediatric Clinical Trials Network

Who can join

Adults 6 to 17, any sex, with Asthma or Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Optimal Dosing Level to Use in Part 2 Primary · 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.

Daily Dose (IU)

Group	Value	95% CI
Vitamin D3 Oral Regimen	8000

Single Loading Dose (IU)

Group	Value	95% CI
Vitamin D3 Oral Regimen	50000

Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml Primary · 16 weeks

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

Group	Value	95% CI
Part 2, Cohort A Vitamin D3 Oral Regimen	0.786	0.641 – 0.883
Part 2, Cohort B Vitamin D Oral Regimen	0	0 – 0.176

Adverse events — posted to ClinicalTrials.gov

Time frame: Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1, Cohort 1 Vitamin D3 Oral Regimen

Serious: 0/13 (0%)

Deaths: 0/13

Part 1, Cohort 2 Vitamin D3 Oral Regimen

Serious: 1/12 (8%)

Deaths: 0/12

Part 1, Cohort 3 Vitamin D3 Oral Regimen

Serious: 1/11 (9%)

Deaths: 0/11

Part 1, Cohort 4 Vitamin D3 Oral Regimen

Serious: 1/12 (8%)

Deaths: 0/12

Part 2, Cohort A Vitamin D3 Oral Regimen

Serious: 0/43 (0%)

Deaths: 0/43

Part 2, Cohort B Vitamin D Oral Regimen

Serious: 1/21 (5%)

Deaths: 0/21

Serious adverse events (2 terms)

Reaction	System	Part 1, Cohort 1 Vitamin D…	Part 1, Cohort 2 Vitamin D…	Part 1, Cohort 3 Vitamin D…	Part 1, Cohort 4 Vitamin D…	Part 2, Cohort A Vitamin D…	Part 2, Cohort B Vitamin D…
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Anaphylactic Reaction	Immune system disorders	—	—	—	—	—	—

Other adverse events (120 terms — click to expand)

Reaction	System	Part 1, Cohort 1 Vitamin D…	Part 1, Cohort 2 Vitamin D…	Part 1, Cohort 3 Vitamin D…	Part 1, Cohort 4 Vitamin D…	Part 2, Cohort A Vitamin D…	Part 2, Cohort B Vitamin D…
asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
headache	Nervous system disorders	—	—	—	—	—	—
hypersensitivity	Immune system disorders	—	—	—	—	—	—
pyrexia	General disorders	—	—	—	—	—	—
rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
asthma	Immune system disorders	—	—	—	—	—	—
coronavirus infection	Infections and infestations	—	—	—	—	—	—
diarrhea	Gastrointestinal disorders	—	—	—	—	—	—
ear infection	Infections and infestations	—	—	—	—	—	—
nasopharyngitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
oropharyngeal pain	Gastrointestinal disorders	—	—	—	—	—	—
oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
vomiting	Gastrointestinal disorders	—	—	—	—	—	—
wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—
abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
acarodermatitis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
acne	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
adenoidectomy	Surgical and medical procedures	—	—	—	—	—	—
adenotonsillectomy	Surgical and medical procedures	—	—	—	—	—	—
alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
amebiasis	Infections and infestations	—	—	—	—	—	—
anaphylactic reaction	Immune system disorders	—	—	—	—	—	—
animal scratch	Injury, poisoning and procedural complications	—	—	—	—	—	—
arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—	—
asthenia	General disorders	—	—	—	—	—	—
cardiac ablation	Surgical and medical procedures	—	—	—	—	—	—
cerumen impaction	Ear and labyrinth disorders	—	—	—	—	—	—
chest cold	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
chest discomfort	General disorders	—	—	—	—	—	—
chills	General disorders	—	—	—	—	—	—
concussion	Injury, poisoning and procedural complications	—	—	—	—	—	—
conjunctivitis	Eye disorders	—	—	—	—	—	—
conjunctivitis	Infections and infestations	—	—	—	—	—	—
constipation	Gastrointestinal disorders	—	—	—	—	—	—
contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—

Most-reported serious reactions: Asthma, Anaphylactic Reaction.

Data from ClinicalTrials.gov NCT03686150 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Obesity-related asthma in children: A role for vitamin D.
O'Sullivan BP, James L, Majure JM, Bickel S, et al · · 2021 · cited 20× · PMID 32930511 · DOI 10.1002/ppul.25053
Management of the pediatric patient with asthma and obesity.
Averill SH, Forno E. · · 2024 · cited 10× · PMID 37827386 · DOI 10.1016/j.anai.2023.10.001
Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial.
O'Sullivan B, Ounpraseuth S, James L, Majure M, et al · · 2024 · cited 6× · PMID 37926939 · DOI 10.1002/cpt.3086
Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study.
James L, O'Sullivan BP, Majure M, Lang J, et al · · 2022 · cited 6× · PMID 35907490 · DOI 10.1016/j.cct.2022.106861
Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma.
Lang JE, Ramirez RG, Balevic S, Bickel S, et al · · 2023 · cited 5× · PMID 37646988 · DOI 10.1007/s40262-023-01285-9
Gaps and Future Directions in Clinical Research on Obesity-Related Asthma.
Hudler AC, Díaz IRR, Sharma S, Holguin F. · · 2023 · cited 5× · PMID 37330948 · DOI 10.1007/s41030-023-00230-2

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

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NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other IDeA States Pediatric Clinical Trials Network trials

Trials by the same sponsor.

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NCT06743425 — A Pilot Study of a Remote ADHD Monitoring Program · NA · recruiting
NCT06479278 — Talk With Me Baby to Enhance the Early Home Language Environment · NA · recruiting
NCT05994183 — The Bronchiolitis in Hospitalized Infants Study · EARLY_PHASE1 · withdrawn
NCT05615870 — Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03686150 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by IDeA States Pediatric Clinical Trials Network
Last refreshed: 19 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03686150.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing