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Different Doses of Vitamin A and Childhood Morbidity and Mortality

Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00168584
Enrollment
5400
Registered
2005-09-15
Start date
2002-11-30
Completion date
2003-08-31
Last updated
2005-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbidity, Mortality

Keywords

Vitamin A, Mortality, Morbidity, Doses, OPV

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.

Detailed description

Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far. With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality.

Interventions

DRUGVitamin A

Sponsors

Bandim Health Project
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No

Inclusion criteria

Between 6 mo and 5 years old and thus eligible for OPV and vitamin A during national immunisation day \-

Exclusion criteria

Children with overt signs of vitamin A deficiency will not be enrolled in the study, but treated according to the recommendations. -

Design outcomes

Primary

MeasureTime frame
Mortality
Hospitalisations
Morbidity
Growth

Secondary

MeasureTime frame
Rotavirus infection

Countries

Guinea-Bissau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026