At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 807 enrolled

Drug / intervention

Vitamin A +1 moredrug

Likely dose

Vitamin A 5,000 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/NCT01203488

NCT01203488Phase 2Completed

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Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight

NICHD Neonatal Research Network·interventional·Posted Sep 16, 2010·Updated Sep 26, 2017

In Brief

A Phase 2 clinical trial evaluating Vitamin A and Sham Procedure for Infant, Newborn and 7 related conditions. Completed, enrolled 807 participants across 11 sites.

Detailed Summary

This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the Vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Respiration, Artificial, Respiratory Distress Syndrome, Newborn, Sepsis

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 2CompletedFinished

19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 1996

Primary CompletionJul 1997

Study CompletionJul 1999

First PostedSep 2010

TodayJul 2026

First PostedSep 16, 2010

Enrollment StartJan 1, 1996

Primary CompletionJul 1, 1997

Study CompletionJul 1, 1999

TodayJul 1, 2026

Enrollment to primary: 1.5 yearsPosted 15.8 years ago

Interventions

Vitamin Adrug

5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.

Sham Procedureother

Control infants received a sham procedure rather than placebo injections.