Iron-fortified Whole Maize Flour Trial

Phase 2

Completed

• Conditions: Anaemia

• Registration Number: NCT00386074
• Lead Sponsor: Wageningen University

Brief 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.

Study Timeline

• Study Start: 2004-05
• Study Completion: 2004-12
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-20
• Last Update Posted: 2010-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma Transferrin receptor
Haemoglobin
Plasma Ferritin

Secondary Outcome Measures

Name	Time	Method
Iron deficiency anaemia
Anaemia
Iron deficiency