N/A Completed N=112 Randomized Other

Vitamin D Oral Replacement in Asthma

Asthma · Vitamin D deficiency · Pediatric Obesity

Source: ClinicalTrials.gov NCT03686150 ↗

Enrolled (actual)

112

Serious AEs

3.6%

Results posted

Apr 2023

Primary outcomePrimary: Part 1: Optimal Dosing Level to Use in Part 2 — 8000; 50000 IU

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.