Different Doses of Vitamin A Supplementation and Male and Female 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

11000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

Detailed Description

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In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.

We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

Conditions

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Mortality Morbidity

Keywords

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Vitamin A Mortality Morbidity OPV Sex

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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Exclusion 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

References

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Yakymenko D, Benn CS, Martins C, Diness BR, Fisker AB, Rodrigues A, Aaby P. The impact of different doses of vitamin A supplementation on male and female mortality. A randomised trial from Guinea-Bissau. BMC Pediatr. 2011 Sep 1;11:77. doi: 10.1186/1471-2431-11-77.

Reference Type DERIVED

PMID: 21884606 (View on PubMed)

Other Identifiers

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91096-04

Identifier Type: -

Identifier Source: secondary_id

91096-2dos04