Anemia Clinical Trial
Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify
rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the
food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance
the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP
need to be investigated. The primary objectives of the present study are: 1) to test whether
the presence of citrate in iron fortified rice with FePP results in higher iron
bioavailability, and 2) to test whether the presence of citrate in the rice grain during the
extrusion and cooking process results in higher iron bioavailability compared with
iron-fortified rice where citrate has been added shortly before consumption. As a secondary
objective the investigators will compare the absorption from different FePP combinations
with a reference meal fortified with ferrous sulphate. The investigator hypothesize that the
addition of citrate enhances iron absorption and that the positive effect is greater when
the citrate is added during the extrusion.
The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to
evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2)
regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate
added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at
the time of consumption. Iron absorption will be measured as erythrocyte incorporation of
stable iron isotopes at least 14 days after the administration of the isotopically labelled
test meals. The iron absorption from the different meals within the same participant will be
compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.
The present study will provide important data where iron bioavailability from rice is
accurately and directly measured using stable isotopic labels as absorption tracers. This
direct data can be used to base decisions on the level of fortification, can potentially
reduce costs and optimize iron delivery to the targeted population in iron fortification
programs.
n/a
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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