N/A
N=112
Vitamin D Oral Replacement in Asthma
Asthma · Vitamin D Deficiency · Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03686150 ↗Enrolled (actual)
112
Serious AEs
3.6%
Results posted
Apr 2023
Primary outcome: Primary: Part 1: Optimal Dosing Level to Use in Part 2 — 8000; 50000 IU
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D3 oral regimen (Dietary_supplement)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- IDeA States Pediatric Clinical Trials Network
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Optimal Dosing Level to Use in Part 2 |
8000; 50000 | — |
| PRIMARY Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml |
0.786; 0 | 0.0001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03686150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.