Iron-fortified Whole Maize Flour Trial

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wageningen University
• Collaborators: Akzo Nobel; Kenya Medical Research Institute; Unilever Food and Health Research Institute, The Netherlands
• Treatments: Fe(III)-EDTA; Iron

Criteria

Inclusion Criteria:Children:

• 3-8 years age (for the purposes of this study this will include children born within the period December 15th 1995- May 1st 2001).

• Whohave been resident in the area for 6 months or more.

• Enrolled in the selected schools

• Able to consume the target amount of porridge, at least 50% of the time during the run-in period

• Will be present in the study area for the entire study period (April - December 2004).

Exclusion Criteria:

• Children below 3 years and above 8 years of age (born after December 15th 1995 and before May 1st 2001).

• Children who have been resident in the area for less than 6 months at the time of recruitment.

• Children with obvious physical and mental disability.

• Severely malnourished children.

• Severely anaemic children (Hb <70g/L).