Iron-fortified Whole Maize Flour Trial

Anaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386074
• Other study ID #: 6107050200
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2006
• Last updated: April 20, 2010
• Start date: May 2004
• Est. completion date: December 2004

Study information

• Verified date: April 2010
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaemia

Intervention

Drug:
• NaFeEDTA, Electrolytic Iron

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Wageningen University	Akzo Nobel, Kenya Medical Research Institute, Unilever Food and Health Research Institute, The Netherlands

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin
Primary	Plasma Ferritin
Primary	Plasma Transferrin receptor
Secondary	Iron deficiency anaemia
Secondary	Iron deficiency
Secondary	Anaemia