Ferrous Fumarate and Ferric Pyrophosphate as Food Fortificants in Developing Countries
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
Iron fortification of foods is usually considered the most cost-effective approach to prevent
iron deficiency. However, iron is the most difficult mineral to add to foods. When added as
water-soluble, highly bioavailable compounds such as ferrous sulfate, the soluble iron
rapidly catalyzes fat oxidation resulting in rancid products. In addition, water-soluble iron
compounds can cause unacceptable color reactions during storage and food preparation. Thus,
food manufacturers are often obliged to use water-insoluble iron compounds to fortify foods
and fortification compounds such as elemental Fe powder and ferric pyrophosphate are widely
used to fortify cereal flours and infant cereals. However, these compounds never dissolve
completely in the gastric juice and are usually far less well absorbed than ferrous sulfate
(Hurrell 1997). Ferrous fumarate on the other hand, although almost insoluble in water,
readily dissolves in the gastric juice and has been shown to have an equivalent absorption to
ferrous sulfate in healthy, Western adults (Hurrell et al. 1989, 2000). Because it is
non-water soluble, it causes relatively few sensory problems in the fortified foods and is
therefore an interesting food fortificant. Iron absorption from ferrous fumarate has been
demonstrated to be significantly higher than from ferric pyrophosphate in European infants
(Davidsson et al. 2000) and this compound is currently used to fortify blended cereal flours
for food aid programs and commercial infant cereals in Europe. However, based on our recent
study in Bangladeshi children, there is now concern that due to lower gastric acid output,
young children in developing countries may not be able to absorb ferrous fumarate as well as
Western adults (Davidsson et al. 2001a, Sarker et al. 2001, 2003). Clearly, there is a need
to evaluate the efficacy of water insoluble iron compounds to prevent the development of iron
deficiency/iron deficiency anemia in infants and young children living in developing
countries. The aim of this study is to evaluate the efficacy of ferrous fumarate and ferric
pyrophosphate, as compared to ferrous sulfate, as food fortificants in preventing development
of anemia/IDA in Bangladeshi infants and young children (part I).
A potential cause of low gastric acid secretion in Bangladesh and many developing countries
is Helicobacter pylori infection. Although H. pylori-infection appeared to have no influence
on absorption of ferrous fumarate in children, the impact of chronic H. pylori infection in
adults could be expected to be more pronounced due to long time effects on the gastric
mucosa, resulting in reduced gastric acid output. The other aim of the study is therefore, to
assess of iron absorption and gastric acid output in adult women of child-bearing age with H.
pylori infection (part II).
Two hundred and forty non-anemic Children (Hb>105 g/L) will be randomized to three study
groups; ferrous fumarate, ferric pyrophosphate or ferrous sulfate (n=80 per group) in wheat
flour- and cow milk-based infant formula and will be fed for 9 months. Hemoglobin, serum
ferritin, and transferin receptor will be analyzed at baseline and after 4.5 and 9 months of
intervention. Prevalence of anemia and iron deficiency during and after the intervention
among the three groups will be compared (part I). We furthermore propose a complementary
study to determine the relative absorption of ferrous fumarate (relative to ferrous sulfate)
in H. pylori infected and non-infected adult Bangladeshi women (15 each) of 20-40 year of age
with IDA using stable isotope technique based on the incorporation of iron stable isotopes
into erythrocytes 14 days after administration. Assessment of gastric acid output will also
be performed. Iron stature and absorption, and assessment of gastric acid output will be
compared before and after therapy in H. pylori infected women (part II). The results of this
study are expected to have implications in the prevention and treatment of iron deficiency
anemia in developing countries
Phase:
Phase 1
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh