NCT00168597

Brief Summary

Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. 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 normal birth weight children in an African setting.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
4,800

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 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

11.3 years

First QC Date

September 9, 2005

Last Update Submit

November 14, 2013

Conditions

MortalityMorbidity

Keywords

Vitamin ABCGInfant mortalityMorbidityLow-income country

Outcome Measures

Primary Outcomes (2)

  • Mortality

  • Hospitalisations

Secondary Outcomes (10)

  • Adverse effects

  • Tuberculin reaction

  • BCG scarring

  • Growth

  • Vitamin A status

  • +5 more secondary outcomes

Interventions

Vitamin ADRUG

Eligibility Criteria

AgeUp to 1 Year
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 (7)

  • Aage S, Kiraly N, Da Costa K, Byberg S, Bjerregaard-Andersen M, Fisker AB, Aaby P, Benn CS. Neonatal vitamin A supplementation associated with increased atopy in girls. Allergy. 2015 Aug;70(8):985-94. doi: 10.1111/all.12641. Epub 2015 May 18.

    PMID: 25939706DERIVED

  • Benn CS, Martins CL, Fisker AB, Diness BR, Garly ML, Balde I, Rodrigues A, Whittle H, Aaby P. Interaction between neonatal vitamin A supplementation and timing of measles vaccination: a retrospective analysis of three randomized trials from Guinea-Bissau. Vaccine. 2014 Sep 22;32(42):5468-74. doi: 10.1016/j.vaccine.2014.07.090. Epub 2014 Aug 13.

    PMID: 25131735DERIVED

  • Fisker AB, Aaby P, Rodrigues A, Frydenberg M, Bibby BM, Benn CS. Vitamin A supplementation at birth might prime the response to subsequent vitamin A supplements in girls. Three year follow-up of a randomized trial. PLoS One. 2011;6(8):e23265. doi: 10.1371/journal.pone.0023265. Epub 2011 Aug 11.

    PMID: 21853099DERIVED

  • Diness BR, Christoffersen D, Pedersen UB, Rodrigues A, Fischer TK, Andersen A, Whittle H, Yazdanbakhsh M, Aaby P, Benn CS. The effect of high-dose vitamin A supplementation given with bacille Calmette-Guerin vaccine at birth on infant rotavirus infection and diarrhea: a randomized prospective study from Guinea-Bissau. J Infect Dis. 2010 Sep 1;202 Suppl:S243-51. doi: 10.1086/653569.

    PMID: 20684711DERIVED

  • Benn CS, Diness BR, Roth A, Nante E, Fisker AB, Lisse IM, Yazdanbakhsh M, Whittle H, Rodrigues A, Aaby P. Effect of 50,000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial. BMJ. 2008 Jun 21;336(7658):1416-20. doi: 10.1136/bmj.39542.509444.AE. Epub 2008 Jun 16.

    PMID: 18558641DERIVED

  • Diness BR, Fisker AB, Roth A, Yazdanbakhsh M, Sartono E, Whittle H, Nante JE, Lisse IM, Ravn H, Rodrigues A, Aaby P, Benn CS. Effect of high-dose vitamin A supplementation on the immune response to Bacille Calmette-Guerin vaccine. Am J Clin Nutr. 2007 Oct;86(4):1152-9. doi: 10.1093/ajcn/86.4.1152.

    PMID: 17921396DERIVED

  • Fisker AB, Lisse IM, Aaby P, Erhardt JG, Rodrigues A, Bibby BM, Benn CS. Effect of vitamin A supplementation with BCG vaccine at birth on vitamin A status at 6 wk and 4 mo of age. Am J Clin Nutr. 2007 Oct;86(4):1032-9. doi: 10.1093/ajcn/86.4.1032.

    PMID: 17921381DERIVED

MeSH Terms

Conditions

Infant Death

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and Symptoms

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
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

August 1, 2002

Primary Completion

November 1, 2013

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

GU(1)