Clinical trial NCT00168636: Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality
Official title: The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mortality
Morbidity
Keywords: Vitamin A
Mortality
Morbidity
OPV
Sex
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 11000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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Primary outcomes:
measure: Mortality
measure: Morbidity
measure: All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received
Secondary outcomes:
measure: Rota infection
measure: Measles infection
measure: Growth
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project, Apartado 861
Study officials:
affiliation: Bandim Health Project
name: Peter Aaby, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yakymenko D, Benn CS, Martins C, Diness BR, Fisker AB, Rodrigues A, Aaby P. The impact of different doses of vitamin A supplementation on male and female mortality. A randomised trial from Guinea-Bissau. BMC Pediatr. 2011 Sep 1;11:77. doi: 10.1186/1471-2431-11-77.