Different Doses of Vitamin A and Childhood Morbidity and Mortality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-08-31

Brief Summary

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Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio vaccine in national campaigns. However, it is not clear which dose is optimal. The two studies that have investigated the impact of different doses of vitamin A have both found that a smaller dose was better than a large dose. We therefore investigated if a smaller dose given with oral polio vaccine gives equal or better effect.

Detailed Description

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Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far.

With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality.

Conditions

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Mortality Morbidity

Keywords

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Vitamin A Mortality Morbidity Doses OPV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Vitamin A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Peter Aaby, DMSc

Role: PRINCIPAL_INVESTIGATOR

Bandim Health Project

Locations

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Bandim Health Project, Apartado 861

Bissau, , Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

Other Identifiers

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91096-02

Identifier Type: -

Identifier Source: secondary_id

91096-2dos02