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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00741143
Enrollment
194
Registered
2008-08-26
Start date
2007-08-31
Completion date
2008-03-31
Last updated
2008-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition, Iron Deficiency, Iron Deficiency Anemia

Keywords

Food Fortification, Iron deficiency, NaFeEdta, Iron deficiency anemia, Cognition

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.

Interventions

OTHERFortification 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

Sponsors

Akzo Nobel
CollaboratorINDUSTRY
Ministry of Science and Technology, India
CollaboratorOTHER_GOV
St. John's Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
change in cognitive abilities7 months

Secondary

MeasureTime frame
changes in iron status indicators7 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026