Phase 4
N=300
Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
Wheezing · Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01601847 ↗Enrolled (actual)
300
Serious AEs
24.7%
Results posted
Jun 2018
Primary outcome: Primary: Number of Infants With Recurrent Wheezing — 42; 56 Participants — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cholecalciferol (Dietary_supplement); Cholecalciferol (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infants With Recurrent Wheezing |
42; 56 | 0.02 sig |
| SECONDARY Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay |
7; 3 | 0.228 |
| SECONDARY Bone Density |
3155; 3149 | 0.798 |
Summary
The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D needs, and inappropriate supplementation may promote wheezing or allergy. The results of this study will help form nutritional recommendations for the approximately 100,000 black infants born at 30-36 weeks gestational age in the U.S. every year.
Eligibility Criteria
Inclusion criteria
- 28 0/7-36 6/7 weeks gestational age (GA) at birth;
- family identifies the child as black or African American;
- 28 days of supplemental oxygen);
- pre-existing diagnosis of moderate to severe osteopenia of prematurity and/or alkaline phosphatase > 700;
- history of fracture;
- gastrointestinal surgery, including for NEC;
- known gastrointestinal malabsorption;
- major congenital anomaly;
- congenital pulmonary or airway disorder (e.g., cystic fibrosis, tracheomalacia, swallowing disorder, bronchopulmonary sequestration);
- documented wheezing or stridor prior to enrollment;
- previous vit. D supplementation with > 400 IU/day;
- family plans to move more than 60 miles from CWRU or other pre-defined radius at other sites;
- baseline hypo- or hypercalcemia, hypo- or hyperphosphatemia; and
- baseline 25(OH) D level < 10 ng/ml.
Data sourced from ClinicalTrials.gov (NCT01601847). 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.