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

NCT01601847 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-06-08

Study results available
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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.

Conditions

  • Wheezing
  • Allergy

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

Once 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

Cholecalciferol

Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Office of Dietary Supplements (ODS)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Anna Maria Hibbs, MD, MSCE · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-03-12
Completion
2017-03-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01601847 on ClinicalTrials.gov