Ferric Pyrophosphate-fortified Rice for the Prevention of Iron Deficiency Anemia in Infants and Preschoolers: A Double-Blind Cluster-Randomized Controlled Trial

Background: Globally, it is estimated that 47% of children under the age of five years suffer from iron
deficiency anemia (IDA).
Objective: To investigate the impact of rice fortified with ferric pyrophosphate iron, given once
weekly, in infants and preschoolers compared with control (standard household rice) on hemoglobin
(Hb) concentrations and anemia prevalence rates.
Methods: This randomized controlled trial was conducted in the northeast of Brazil, between August
and December 2010. The study population comprised of infants from two day-care centers (n=171),
and preschoolers from two public schools (n=303). Fortified rice was allocated to 1 day-care center
and 1 public school, and standard household rice to the other center and school. Two primary
outcome variables were analyzed: change in Hb concentration and anemia prevalence before and
after intervention. Hb concentration <11.0 g/dL was used as cutoff point to define anemia.
Results: At the infant day-care centers, for the fortified rice group, there was significant increase in
mean Hb concentration (p< .0001) and reduction in anemia prevalence (p= .012). At baseline the daycare
centers were statistically similar for Hb; however, at endpoint there was a significant difference
between groups, p= .027. For the preschoolers, there was no significant change in mean Hb
concentration or anemia prevalence in the before-and-after analysis. The number needed to treat
(considering all groups) was 4.
Conclusions: For infants, rice fortified with iron once weekly increased Hb levels, reduced anemia
prevalence, and prevented anemia; for preschoolers, this same intervention was of use in the
prevention of IDA.