Iron Deficiency Clinical Trial
Official title:
Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads.
Iron deficiency anaemia affects around two billion people worldwide. Food fortification with
iron is a realistic way to combat this problem. Water soluble forms of iron are considered
to be more bioavailable than nonsoluble iron compounds. However, the former often cause
sensory problems when added to foods, while the latter cause fewer problems but are not
generally well absorbed and are therefore ineffective as fortificants. A potential strategy
for overcoming this problem is the use of water soluble iron compounds protected by a water
resistant barrier, which will prevent potential organoleptic changes within fortified foods
and protect the iron (from oxidation) through the digestion process thus increasing its
availability. The investigators will use alginate, in the form of alginate beads, as a
protective barrier for soluble iron gluconate. It has been shown that alginates bind
divalent and trivalent cations and therefore may be a useful vehicle for soluble iron
compounds to fortify foods.
The aim of this project is to measure the effect of alginate on iron absorption from ferrous
gluconate and assess the potential modulating effect of calcium on iron absorption in the
presence and absence of alginate.
This study is a randomised, single blinded, cross-over trial with participants randomly
allocated into two groups: A (n= 8 volunteers) and B (n=8 volunteers). The study will
include a total of four arms.
By administration of test meals #1 (iron in alginate beads) and #4 (iron in a capsule) the
possible protective effect of alginate on iron absorption will be investigated. By
administration of test meal #2 (iron in alginate beads + calcium capsule)and #3 (iron in a
capsule + calcium in a capsule)the study will investigate whether alginates can bind calcium
(a well-known iron inhibitor) in vivo, thus diminish the potential negative effect of
calcium on iron absorption.
Only half (8) of the volunteers will undergo treatments including calcium. Therefore group A
will undergo all 4 tests, whereas group B will undergo 2 out of 4 tests.
The four test meals will be administered a week apart following an overnight fast. On each
occasion blood sampling will take place over a period of 6h with samples taken via a cannula
at t=0, 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Serum samples will be
analysed for iron content allowing calculation of iron absorption.
The assumptions made for the power calculation to estimate the number of volunteers are that
a difference of 2.5% in iron absorption in the presence and absence of alginate ( test meal
#1 and test meal #4) will be nutritionally significant. A minimum of 12 volunteers would be
required to complete the study to detect a difference of 2.5% at a significance level of
0.05 for 80% power. A minimum of 8 volunteers would be required to detect a significant
difference in iron absorption of 3.3% between a test meal containing 20mg of iron as iron
gluconate with calcium and a test meal containing 20mg of iron as iron gluconate with
calcium and alginate beads (test meals #2 and #3). This assumes a power of 80%, a level of
significance of 0.05 and standard deviation of differences (within pairs) of 2.8%
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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