NCT00386074

Iron-fortified Whole Maize Flour Trial

The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 412 (planned)
• Sponsor: Wageningen University · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.

Detailed description

Fortification of staple foods with iron may be an effective method of addressing the problem of iron deficiency. Questions however remain of the type of iron fortificants to use, the appropriate fortification levels and suitable food vehicles. Cereals form attractive vehicles because they are widely consumed in parts of the world that bear a large burden of the iron deficiency problem. They are however high in phytates and would reduce the bioavailability of commonly used iron fortificants. Isotope studies have shown that even in the presence of phytates, iron from NaFeEDTA is relatively more bioavailable than that from other fortificant sources. Its efficacy has however not been assessed in human trials. Electrolytic iron, on the other hand is widely used and was legislated as the iron fortificant of choice in South Africa. Its efficacy in a high-phytate vehicle has also not been assessed. We have therefore undertaken to assess the efficacy of NaFeEDTA at two doses, as an iron fortificant in whole flour, and the efficacy of electrolytic iron at a dose similar to the high-dose NaFeEDTA. The results will contribute information on the suitability of these fortificants in whole maize flour, a food commonly consumed in sub-Saharan Africa.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	NaFeEDTA, Electrolytic Iron

Timeline

• Start date: 2004-05-01
• Completion: 2004-12-01
• First posted: 2006-10-11
• Last updated: 2010-04-21