NCT00168636

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,000

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

9 years

First QC Date

September 12, 2005

Last Update Submit

November 14, 2013

Conditions

Keywords

Vitamin AMortalityMorbidityOPVSex

Outcome Measures

Primary Outcomes (3)

  • Mortality

  • Morbidity

  • All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received

Secondary Outcomes (3)

  • Rota infection

  • Measles infection

  • Growth

Interventions

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project, Apartado 861

Bissau, Guinea-Bissau

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coitus

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Peter Aaby, DMSc

    Bandim Health Project

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2004

Primary Completion

November 1, 2013

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations