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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | October 10, 2006 | ||||||||||||||||||||
| Last Updated Date | October 10, 2006 | ||||||||||||||||||||
| Start Date ICMJE | May 2004 | ||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Iron-Fortified Whole Maize Flour Trial | ||||||||||||||||||||
| Official Title ICMJE | The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya | ||||||||||||||||||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||||||||||||||
| Condition ICMJE | Anaemia | ||||||||||||||||||||
| Intervention ICMJE | Drug: NaFeEDTA, Electrolytic Iron | ||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||
| 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):1799-806. | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||
| Enrollment ICMJE | 412 | ||||||||||||||||||||
| Completion Date | December 2004 | ||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Children:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 3 Years to 8 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | |||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00386074 | ||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||
| Study ID Numbers ICMJE | 6107050200 | ||||||||||||||||||||
| Study Sponsor ICMJE | Wageningen University | ||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Wageningen University | ||||||||||||||||||||
| Verification Date | October 2006 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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