Iron Deficiency Clinical Trial
Official title:
Relative Bioavailability of Ferric Pyrophosphate From an Apple Juice Drink
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Basic Science
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