Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474682
Status:
COMPLETED
Last Update Posted:
2008-12-03
First Post:
2007-05-16
Brief Title:
Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink
Sponsor:
Quadram Institute Bioscience
Organization:
Quadram Institute Bioscience
Study Overview
Official Title:
Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink
Status:
COMPLETED
Status Verified Date:
2007-05
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 aim of this study is to find out how well iron is absorbed when a newly developed form of ferric pyrophosphate is added to a commercial apple juice drink
Detailed Description:
Micronized dispersible ferric pyrophosphate MDFP is an iron compound that has been reported to be highly bioavailable and likely to cause few sensory problems when added to food It is therefore a potentially effective iron additive for the food industry and is particularly formulated for adding to liquids A randomized cross-over trial will be undertaken to compare the absorption of iron added to a commercial apple juice drink as MDFP with iron added as ferrous sulphate The null hypothesis is that absorption of iron added as MDFP is not different to absorption from iron added as ferrous sulphate
The study population will consist of 16 women age 18-65 with iron stores at the lower end of the normal range This group will efficiently absorb bioavailable iron and will be sensitive to differences in bioavailability between different forms of iron Test drinks containing added iron labelled with stable isotopes of iron Fe-57 or Fe-58 will be consumed on two consecutive days Iron absorption from the drinks will be determined using the erythrocyte incorporation technique A baseline blood sample will be taken prior to consuming the test drinks and then a second blood sample will be taken 14 days after the last test drink Iron absorption will be calculated from the isotopic enrichment of the final blood sample assuming that 80 of absorbed iron is incorporated into red blood cells The order in which the volunteers will be given the MDFP or ferrous sulphate will be randomised
The study population will consist of 16 women age 18-65 with iron stores at the lower end of the normal range This group will efficiently absorb bioavailable iron and will be sensitive to differences in bioavailability between different forms of iron Test drinks containing added iron labelled with stable isotopes of iron Fe-57 or Fe-58 will be consumed on two consecutive days Iron absorption from the drinks will be determined using the erythrocyte incorporation technique A baseline blood sample will be taken prior to consuming the test drinks and then a second blood sample will be taken 14 days after the last test drink Iron absorption will be calculated from the isotopic enrichment of the final blood sample assuming that 80 of absorbed iron is incorporated into red blood cells The order in which the volunteers will be given the MDFP or ferrous sulphate will be randomised
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