NCT00741143

Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: St. John's Research Institute · Academic / Other
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Iron Deficiency
• Iron Deficiency Anemia
• Cognition

Interventions

Type	Name	Description
OTHER	Fortification of wheat flour with NaFeEdta	NaFeEdta Fortified Wheat Flour (100g)provided as a lunch meal. Fortification level of 6mg Fe/100g/day/child for 7 months

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-08-26
• Last updated: 2008-08-26

Locations

1 site across 1 country: India