NCT00168584

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2002

Shorter than P25 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, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.1 years 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
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

MortalityMorbidity

Keywords

Vitamin AMortalityMorbidityDosesOPV

Outcome Measures

Primary Outcomes (4)

  • Mortality

  • Hospitalisations

  • Morbidity

  • Growth

Secondary Outcomes (1)

  • Rotavirus infection

Interventions

Vitamin ADRUG

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

MeSH Terms

Interventions

Vitamin A

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, 2002

Study Completion

August 1, 2003

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

GU(1)