Status:
COMPLETED
Iron-fortified Whole Maize Flour Trial
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Unilever Food and Health Research Institute, The Netherlands
Kenya Medical Research Institute
Conditions:
Anaemia
Eligibility:
All Genders
3-8 years
Phase:
PHASE2
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 forti...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00386074
Start Date
May 1 2004
End Date
December 1 2004
Last Update
April 21 2010
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