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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
194
NaFeEdta Fortified Wheat Flour (100g)provided as a lunch meal. Fortification level of 6mg Fe/100g/day/child for 7 months
St Johns Research Institute
Bangalore, Karnataka, India
change in cognitive abilities
Time frame: 7 months
changes in iron status indicators
Time frame: 7 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.