Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy

Completed · Phase 4 · Has a placebo group

Conditions studied: Wheezing, Allergy

In brief

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.

Key facts

Study ID

NCT01601847

Run by

Case Western Reserve University

People needed

300

Starts

2013-01-01

Expected to finish

2017-03-12

Last updated by the study team

2018-06-08

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (subsequent oxygen therapy for < 72 hrs for a brief subsequent illness or surgery will be allowed);
• admitted to a participating site NICU, special care nursery, transitional care nursery, or well-baby nursery as a neonate; and
• < 40 weeks corrected GA at enrollment.

You may not qualify if…

• BPD (> 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.

Where it is running

• Montefiore Medical Center — New York, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University Hospitals — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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