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Vitamin A Supplementation With Bacille Calmette Guerin (BCG) Vaccine

NCT00168610 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7600

Last updated 2013-11-15

No results posted yet for this study

Summary

In the present study the investigators wish to address the effects of different doses of vitamin A supplementation in low and normal birth weight infants.

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 both normal and low birth weight infants.
* A lower dose of vitamin A may be even more beneficial than a high dose.

Conditions

  • Infant Mortality
  • Morbidity

Interventions

DRUG

Vitamin A

Sponsors & Collaborators

  • March of Dimes

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Medical Research Council Unit, The Gambia

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30

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 NCT00168610 on ClinicalTrials.gov