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Sponsors and Collaborators: |
Wageningen University Unilever Food and Health Research Institute, The Netherlands Kenya Medical Research Institute Akzo Nobel |
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Information provided by: | Wageningen University |
ClinicalTrials.gov Identifier: | NCT00386074 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya |
Estimated Enrollment: | 412 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | December 2004 |
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.
Ages Eligible for Study: | 3 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Children:
Exclusion Criteria:
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 |
Study ID Numbers: | 6107050200 |
Study First Received: | October 10, 2006 |
Last Updated: | October 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00386074 |
Health Authority: | Kenya: Ethical Review Committee |
NaFeEDTA electrolytic iron efficacy whole maize flour |
phytate school-age children controlled trial Africa |
Fe(III)-EDTA Anemia Iron |
Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Iron Chelating Agents |
Trace Elements Chelating Agents Micronutrients Pharmacologic Actions |