CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14,035 enrolled
Drug / intervention
Vitamin Adrug
Likely dose
Not stated in 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/NCT00114868
NCT00114868Phase 3Completed

Vitamin A Supplementation in Newborns Study

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jun 20, 2005·Updated Mar 3, 2017

In Brief

A Phase 3 clinical trial evaluating Vitamin A for Infant, Newborn. Completed, enrolled 14,035 participants across 1 site.

Detailed Summary

This study was a randomized, community-based trial testing whether dosing newborn infants in the first few days after delivery with a large dose of vitamin A could reduce early infant morbidity, mortality and improve growth. Pregnant women in 2 districts of Tamil Nadu State in southern India were identified and recruited for participation. When the child was born, study staff were notified and traveled to the house to collect information and provide the vitamin A or placebo dose. Children were visited every two weeks until they were 6 months of age to collect information about vital status and morbidity. All children were discharged from the study at 6 months after growth was assessed and they received a 100,000 IU dose of vitamin A.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn
CountriesIndia

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2005
Enrollment StartJun 1, 1998
Primary CompletionApr 1, 2001
TodayJul 3, 2026
Enrollment to primary: 2.8 yearsPosted 21.0 years ago

Interventions

Vitamin Adrug