Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink
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|ClinicalTrials.gov Identifier: NCT00474682|
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : December 3, 2008
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency||Drug: Micronized dispersible ferric pyrophosphate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink|
- Relative bioavailability of Micronized dispersible ferric pyrophosphate added to apple juice [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474682
|Institute of Food Research|
|Norwich, Norfolk, United Kingdom, NR4 6JF|
|Principal Investigator:||Susan J Fairweather-Tait||University of East Anglia|