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Completed

NCT Number: NCT00168584

Different Doses of Vitamin A and Childhood Morbidity and Mortality

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.

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Key information

Conditions

Mortality Morbidity

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bandim Health Project, Apartado 861

Bissau, Guinea-Bissau

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Vitamin A

Drug

Primary outcomes

  1. Mortality

  2. Hospitalisations

  3. Morbidity

  4. Growth

Secondary outcomes

  1. Rotavirus infection

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
Sep 15, 2005
Registry last updated
Sep 15, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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