Iron-fortified Whole Maize Flour Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Anaemia
• Intervention / Treatment: Drug: NaFeEDTA, Electrolytic Iron

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 Type: Interventional
• Enrollment: 412
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Haemoglobin
Plasma Ferritin
Plasma Transferrin receptor

Secondary Outcome Measures

Outcome Measure
Iron deficiency anaemia
Iron deficiency
Anaemia

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Kenya Medical Research Institute; Akzo Nobel; Unilever Food and Health Research Institute, The Netherlands
• Investigators: Principal Investigator: Pauline EA Andang'o, MND, Wageningen University; Principal Investigator: David L Mwaniki, PhD, Kenya Medical Research Institute; Principal Investigator: Hans Verhoef, PhD, Wageningen University; Study Director: Saskia JM Osendarp, PhD, Unilever Food and Health Institute, Vlaardingen, The Netherlands; Study Chair: Frans J Kok, PhD, Wageningen University

Publications and helpful links

General Publications

• Andang'o PE, Osendarp SJ, Ayah R, West CE, Mwaniki DL, De Wolf CA, Kraaijenhagen R, Kok FJ, Verhoef H. Efficacy of iron-fortified whole maize flour on iron status of schoolchildren in Kenya: a randomised controlled trial. Lancet. 2007 May 26;369(9575):1799-1806. doi: 10.1016/S0140-6736(07)60817-4.

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Study Completion: December 1, 2004

Study Registration Dates

• First Submitted: October 10, 2006
• First Submitted That Met QC Criteria: October 10, 2006
• First Posted (Estimate): October 11, 2006

Study Record Updates

• Last Update Posted (Estimate): April 21, 2010
• Last Update Submitted That Met QC Criteria: April 20, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: efficacy; Africa; controlled trial; NaFeEDTA; school-age children; phytate; electrolytic iron; whole maize flour
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Fe(III)-EDTA
• Other Study ID Numbers: 6107050200