Wheezing | Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
Wheezing research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion criteria: 1. 28 0/7-36 6/7 weeks gestational age (GA) at birth; 2. family identifies the child as black or African American; 3. < 28 days of supplemental oxygen (subsequent oxygen therapy for < 72 hrs for a brief subsequent illness or surgery will be allowed); 4. admitted to a participating site NICU, special care nursery, transitional care nursery, or well-baby nursery as a neonate; and 5. < 40 weeks corrected GA at enrollment. Exclusion criteria: 1. BPD (> 28 days of supplemental oxygen); 2. pre-existing diagnosis of moderate to severe osteopenia of prematurity and/or alkaline phosphatase > 700; 3. history of fracture; 4. gastrointestinal surgery, including for NEC; 5. known gastrointestinal malabsorption; 6. major congenital anomaly; 7. congenital pulmonary or airway disorder (e.g., cystic fibrosis, tracheomalacia, swallowing disorder, bronchopulmonary sequestration); 8. documented wheezing or stridor prior to enrollment; 9. previous vit. D supplementation with > 400 IU/day; 10. family plans to move more than 60 miles from CWRU or other pre-defined radius at other sites; 11. baseline hypo- or hypercalcemia, hypo- or hyperphosphatemia; and 12. baseline 25(OH) D level < 10 ng/ml.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:CholecalciferolOnce the dietary intake of vitamin D has exceeded 200 IU/Day, the infants will receive placebo until they are 6 months of age adjusted for prematurity
Drug:CholecalciferolInfants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
SustainedInfants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake
Diet-LimitedInfants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day
Start Date: January 2013
Completed Date: March 12, 2017
Phase: Phase 4
Primary Outcome: Number of Infants With Recurrent Wheezing
Secondary Outcome: Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay
Study sponsors, principal investigator, and references
Principal Investigator: Anna Maria Hibbs, MD, MSCE
Lead Sponsor: Case Western Reserve University
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)