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Different Doses of Vitamin A and Childhood Morbidity and Mortality
This study has been completed.
Study NCT00168584   Information provided by Bandim Health Project
First Received: September 12, 2005   No Changes Posted

September 12, 2005
September 12, 2005
November 2002
 
  • Mortality
  • Hospitalisations
  • Morbidity
  • Growth
Same as current
No Changes Posted
Rotavirus infection
Same as current
 
Different Doses of Vitamin A and Childhood Morbidity and Mortality
Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality

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.

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.

Phase IV
Interventional
Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment
  • Mortality
  • Morbidity
Drug: Vitamin A
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
5400
August 2003
 

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. -

Both
6 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
NCT00168584
 
91096-2dos02, 91096-02
Bandim Health Project
 
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
Bandim Health Project
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP