Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00168636
Enrollment
11000
Registered
2005-09-15
Start date
2004-11-30
Completion date
Unknown
Last updated
2013-11-15

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, OPV, Sex

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.

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

Exclusion criteria

Overt signs of vitamin A deficiency \-

Design outcomes

Primary

MeasureTime frame
Mortality
Morbidity
All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received

Secondary

MeasureTime frame
Rota infection
Measles infection
Growth

Countries

Guinea-Bissau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026