Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386074
Status:
COMPLETED
Last Update Posted:
2010-04-21
First Post:
2006-10-10
Brief Title:
Iron-fortified Whole Maize Flour Trial
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None