Iron-fortified Whole Maize Flour Trial

NCT ID: NCT00386074

Last Updated: 2010-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2004-12-31

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.

Conditions

Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

NaFeEDTA, Electrolytic Iron

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unilever Food and Health Research Institute, The Netherlands

UNKNOWN

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Akzo Nobel

INDUSTRY

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: lead

Principal Investigators

Pauline EA Andang'o, MND

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

David L Mwaniki, PhD

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Hans Verhoef, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Saskia JM Osendarp, PhD

Role: STUDY_DIRECTOR

Unilever Food and Health Institute, Vlaardingen, The Netherlands

Frans J Kok, PhD

Role: STUDY_CHAIR

Wageningen University

References

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.

Reference Type: DERIVED

PMID: 17531887 (View on PubMed)

Other Identifiers

6107050200

Identifier Type: -

Identifier Source: org_study_id