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

• Status: Completed
• Trial end date: 2017-03-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Western Reserve University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Office of Dietary Supplements (ODS)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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.