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CompletedNCT00386074Updated Apr 21, 2010

Iron-fortified Whole Maize Flour Trial

A Phase 2 interventional study of NaFeEDTA, Electrolytic Iron in Anaemia, sponsored by Wageningen University. Completed. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2010-04-21.

Sponsored by Wageningen University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
412
Allocation
Randomized
Ages
3 Years to 8 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anaemia

Keywords

  • NaFeEDTA
  • electrolytic iron
  • efficacy
  • whole maize flour
  • phytate
  • school-age children
  • controlled trial
  • Africa
03

In context

Lead sponsor

Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
412 participants

Interventions

  • DrugNaFeEDTA, Electrolytic Iron
06

What researchers measure

Primary outcomes

  1. Haemoglobin

  2. Plasma Ferritin

  3. Plasma Transferrin receptor

Secondary outcomes

  1. Iron deficiency anaemia

  2. Iron deficiency

  3. Anaemia

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17531887 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00386074
Lead sponsor
Wageningen University
Collaborators
Unilever Food and Health Research Institute, The Netherlands, Kenya Medical Research Institute, Akzo Nobel
First posted
Oct 11, 2006
Start date
May 2004
Completion
Dec 2004
Last update
Apr 21, 2010

Study contacts

Pauline EA Andang'o, MND
principal investigator · Wageningen University
David L Mwaniki, PhD
principal investigator · Kenya Medical Research Institute
Hans Verhoef, PhD
principal investigator · Wageningen University
Saskia JM Osendarp, PhD
study director · Unilever Food and Health Institute, Vlaardingen, The Netherlands
Frans J Kok, PhD
study chair · Wageningen University
View the source record on ClinicalTrials.gov ↗

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