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Vitamin A Supplementation in Newborns Study

NCT00114868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14035

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

  • Infant, Newborn

Interventions

DRUG

Vitamin A

Sponsors & Collaborators

  • Aravind Centre for Women and Children, Madurai, Tamil Nadu, India

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • James M Tielsch, PhD · Johns Hopkins Bloomberg School of Public Health

  • Lakshmi Rahmathullah, MBBS · Aravind Center for Women and Children

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-06-30
Primary Completion
2001-04-30
Completion
2001-04-30

Countries

  • India

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 NCT00114868 on ClinicalTrials.gov