Different Doses of Vitamin A and Childhood Morbidity and Mortality

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168584
• Other study ID #: 91096-2dos02
• Secondary ID: 91096-02
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: November 2002
• Est. completion date: August 2003

Study information

• Verified date: September 2005
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5400
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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. -

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	Hospitalisations
Primary	Morbidity
Primary	Growth
Secondary	Rotavirus infection