Iron-fortified Whole Maize Flour Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386074
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : April 21, 2010
Unilever Food and Health Research Institute, The Netherlands
Kenya Medical Research Institute
Akzo Nobel
Information provided by:
Wageningen University

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.

Condition or disease Intervention/treatment Phase
Anaemia Drug: NaFeEDTA, Electrolytic Iron Phase 2

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  (Clinical Trial)
Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya
Study Start Date : May 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Primary Outcome Measures :
  1. Haemoglobin
  2. Plasma Ferritin
  3. Plasma Transferrin receptor

Secondary Outcome Measures :
  1. Iron deficiency anaemia
  2. Iron deficiency
  3. Anaemia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00386074

Sponsors and Collaborators
Wageningen University
Unilever Food and Health Research Institute, The Netherlands
Kenya Medical Research Institute
Akzo Nobel
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 automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00386074     History of Changes
Other Study ID Numbers: 6107050200
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: April 21, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Trace Elements
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action