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

Not Applicable

Completed

• Conditions: Iron Deficiency; Iron Deficiency Anemia; Cognition
• Interventions: Other: Fortification of wheat flour with NaFeEdta

• Registration Number: NCT00741143
• Lead Sponsor: St. John's Research Institute

Brief 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.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-08
• Study First Submitted: 2008-08-23
• Study First Submitted QC: 2008-08-25
• Last Update Submitted: 2008-08-25
• Study First Posted: 2008-08-26
• Last Update Posted: 2008-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• Children with depleted iron stores (serum ferritin < 20 µg/L or iron deficiency serum transferrin receptor >7.6 mg/L)

Exclusion Criteria

• Hb < 8g/dl, any metabolic illness, use of medication, on iron supplementation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fortification of wheat flour with NaFeEdta	Group that receives NaFeEDTA fortified wheat flour
2	Fortification of wheat flour with NaFeEdta	Unfortified wheat flour

Primary Outcome Measures

Name	Time	Method
change in cognitive abilities	7 months

Secondary Outcome Measures

Name	Time	Method
changes in iron status indicators	7 months

Trial Locations

Locations (1)

St Johns Research Institute; 🇮🇳 Bangalore, Karnataka, India