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Vitamin A With BCG Vaccine

NCT00168597 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4800

Last updated 2013-11-15

No results posted yet for this study

Summary

Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.

Conditions

  • Mortality
  • Morbidity

Interventions

DRUG

Vitamin A

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Medical Research Council Unit, The Gambia

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby, DMSc · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2013-11-30

Countries

  • Guinea-Bissau

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 NCT00168597 on ClinicalTrials.gov