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Iron-fortified Whole Maize Flour Trial

This study has been completed.
Sponsor:
Collaborators:
Unilever Food and Health Research Institute, The Netherlands
Kenya Medical Research Institute
Akzo Nobel
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00386074
First received: October 10, 2006
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Anaemia
 Drug: NaFeEDTA, Electrolytic Iron
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Haemoglobin
  • Plasma Ferritin
  • Plasma Transferrin receptor

Secondary Outcome Measures:
  • Iron deficiency anaemia
  • Iron deficiency
  • Anaemia

Estimated Enrollment: 412
Study Start Date: May 2004
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386074

Sponsors and Collaborators
Wageningen University
Unilever Food and Health Research Institute, The Netherlands
Kenya Medical Research Institute
Akzo Nobel
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
  More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00386074     History of Changes
Other Study ID Numbers: 6107050200
Study First Received: October 10, 2006
Last Updated: April 20, 2010
Health Authority: Kenya: Ethical Review Committee

Keywords provided by Wageningen University:
NaFeEDTA
electrolytic iron
efficacy
whole maize flour
 phytate
school-age children
controlled trial
Africa

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Fe(III)-EDTA
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013