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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00386074
Enrollment
412
Registered
2006-10-11
Start date
2004-05-31
Completion date
2004-12-31
Last updated
2010-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia

Keywords

NaFeEDTA, electrolytic iron, efficacy, whole maize flour, phytate, school-age children, controlled trial, Africa

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.

Interventions

DRUGNaFeEDTA, Electrolytic Iron

Sponsors

Unilever Food and Health Research Institute, The Netherlands
CollaboratorUNKNOWN
Kenya Medical Research Institute
CollaboratorOTHER
Akzo Nobel
CollaboratorINDUSTRY
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Haemoglobin
Plasma Ferritin
Plasma Transferrin receptor

Secondary

MeasureTime frame
Iron deficiency anaemia
Iron deficiency
Anaemia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026