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

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168636
• Other study ID #: 91096-2dos04
• Secondary ID: 91096-04
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 14, 2013
• Start date: November 2004

Study information

• Verified date: November 2013
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11000
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Morbidity
• Mortality

Intervention

Drug:
• Vitamin A

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project, Apartado 861	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Primary	Morbidity
Primary	All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received
Secondary	Rota infection
Secondary	Measles infection
Secondary	Growth