Iron Deficiency Anemia Clinical Trial
Official title:
Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children
This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving cognition, hemoglobin, iron status and total body iron among school children in urban Bangalore.
Background: Iron (Fe) deficiency is a major cause of anemia in children. Fortification of
wheat flour with NaFeEDTA, a highly bioavailable iron fortificant that protects Fe from the
phytic acid present in wheat flour, could be a practical approach to addressing this
problem.
Aims: To evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving mental
performance and reducing iron deficiency and improving body iron stores in urban, school
going Indian children.
Methods: A randomized, double-blind, 7 month, school-based feeding trial was carried out in
Bangalore, India. Iron-depleted (serum ferritin, SF <20 µg/L), and/or iron deficient (serum
transferrin receptor, TfR >7.6 mg/L), 6 -13 year old children (N=194) were randomly assigned
to either receive a whole wheat flour based lunch meal fortified with 6 mg Fe as NaFeEDTA or
an identical unfortified control meal. The meals were administered under supervision and
left overs were weighed. Hemoglobin (Hb) and iron status were measured at baseline, 3.5
months, and 7 months. At baseline and at 7 months, the study children were also subjected to
a battery of cognitive tests to assess attention/concentration, motor development,
visuospatial and verbal abilities. Sensory evaluation using triangle tests were carried out
using meals prepared from the fortified and unfortified whole wheat flour.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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