CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Cholecalciferol +1 moredrug
Likely dose
Cholecalciferol 400 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01601847
NCT01601847Phase 4Completed
CompareCT.gov

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

Case Western Reserve University·interventional·Posted May 18, 2012·Updated Jun 8, 2018

In Brief

A Phase 4 clinical trial evaluating Cholecalciferol for Wheezing and Allergy. Completed, enrolled 300 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWheezing, Allergy
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2012
Enrollment StartJan 1, 2013
Primary CompletionMar 12, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.1 years ago

Interventions

Cholecalciferoldietary

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

Cholecalciferoldrug

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