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Completed

NCT Number: NCT00168636

Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality

We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

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Key information

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

In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.

We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

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 of age and thus eligible for vitamin A and OPV campaign -

Exclusion criteria

Overt signs of vitamin A deficiency

-

Treatment and study plan

Vitamin A

Drug

Primary outcomes

  1. Mortality

  2. Morbidity

  3. All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received

Secondary outcomes

  1. Rota infection

  2. Measles infection

  3. Growth

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality

Important dates

Study start
2004
Primary completion
2013
First posted
Sep 15, 2005
Registry last updated
Nov 15, 2013

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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