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| Name | Class |
|---|---|
| Unilever Food and Health Research Institute, The Netherlands | UNKNOWN |
| Kenya Medical Research Institute | OTHER |
| Akzo Nobel | INDUSTRY |
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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaFeEDTA, Electrolytic Iron | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin | ||
| Plasma Ferritin | ||
| Plasma Transferrin receptor |
| Measure | Description | Time Frame |
|---|---|---|
| Iron deficiency anaemia | ||
| Iron deficiency | ||
| Anaemia |
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Inclusion Criteria:Children:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline EA Andang'o, MND | Wageningen University | Principal Investigator |
| David L Mwaniki, PhD | Kenya Medical Research Institute | Principal Investigator |
| Hans Verhoef, PhD | Wageningen University | Principal Investigator |
| Saskia JM Osendarp, PhD | Unilever Food and Health Institute, Vlaardingen, The Netherlands | Study Director |
| Frans J Kok, PhD | Wageningen University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17531887 | Derived | 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. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C019179 | Fe(III)-EDTA |
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