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

St. John's Research Institute

Status: Completed

Conditions: Iron Deficiency Anemia; Iron Deficiency; Cognition

Treatments: Other: Fortification of wheat flour with NaFeEdta

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00741143

SJRI-BT-PR-8947

BT/PR-8947/FNS/20/325/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

194 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Group that receives NaFeEDTA fortified wheat flour

Treatment:

Other: Fortification of wheat flour with NaFeEdta

2

Placebo Comparator group

Description:

Unfortified wheat flour

Treatment:

Other: Fortification of wheat flour with NaFeEdta