Clinical trial NCT00386074: Iron-fortified Whole Maize Flour Trial
Official title: The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anaemia
Keywords: NaFeEDTA
electrolytic iron
efficacy
whole maize flour
phytate
school-age children
controlled trial
Africa
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Unilever Food and Health Research Institute, The Netherlands
name: Kenya Medical Research Institute
name: Akzo Nobel
First posted: 2006-10-11
Enrollment: 412
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Haemoglobin
measure: Plasma Ferritin
measure: Plasma Transferrin receptor
Secondary outcomes:
measure: Iron deficiency anaemia
measure: Iron deficiency
measure: Anaemia
Other outcomes:
Locations:
Study officials:
affiliation: Wageningen University
name: Pauline EA Andang'o, MND
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: David L Mwaniki, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University
name: Hans Verhoef, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unilever Food and Health Institute, Vlaardingen, The Netherlands
name: Saskia JM Osendarp, PhD
role: STUDY_DIRECTOR
affiliation: Wageningen University
name: Frans J Kok, PhD
role: STUDY_CHAIR
References:
citation: 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.