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Status unknownNCT00168623Updated Nov 15, 2013

Vitamin A Supplementation With Routine Childhood Vaccines and Mortality and Morbidity

A Phase 4 interventional study of Vitamin A in Mortality and Morbidity, sponsored by Bandim Health Project. Status unknown at 1 site in Guinea-Bissau. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2013-11-15.

Sponsored by Bandim Health Project · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
6,200
Allocation
Randomized
Ages
6 Months to 5 Years
Sex
All
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Study summary

Vitamin A supplementation (VAS) is important for the immune system and may interact with different childhood vaccinations. We have hypothesized that the improved survival after VAS may depend on vitamin A amplifying the non-specific immune modulation induced by vaccinations.

In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

Read the detailed description

Vitamin A supplementation (VAS) acts as an adjuvant to vaccines, and VAS has been shown to enhance both cellular and humoral immune responses in animals and in humans. Routine childhood vaccinations have recently been shown to have important non-targeted effects on mortality, i.e. effects that cannot be explained merely by the prevention of the targeted disease. We have hypothesized that the improved survival after VAS may depend not only on the prevention of vitamin A deficiency, but also on vitamin A amplifying the non-specific immune modulation induced by routine vaccinations.

In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

02

Conditions studied

  • Mortality
  • Morbidity

Keywords

  • Vitamin A
  • Vaccines
  • Mortality
  • Morbidity
03

In context

Lead sponsor

Bandim Health Project is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:Between 6 months and 5 years and thus eligible for vitamin A and missing vaccines during national immunisation days -

Exclusion Criteria: Overt signs of vitamin A deficiency

-

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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6,200 participants

Interventions

  • DrugVitamin A
06

What researchers measure

Primary outcomes

  1. Mortality

  2. Morbidity

  3. Both outcomes analysed according to vaccine received and sex

07

Study locations

1 site
  • Bandim Health Project, Apartado 861
    Bissau, Guinea-Bissau
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00168623
Lead sponsor
Bandim Health Project
First posted
Sep 15, 2005
Start date
Nov 2003
Completion
Dec 2014 (estimated)
Last update
Nov 15, 2013

Study contacts

Peter Aaby, DMSc
principal investigator · Bandim Health Project
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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