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

August 25, 2008 updated by: St. John's Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • St Johns Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Group that receives NaFeEDTA fortified wheat flour
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
Placebo Comparator: 2
Unfortified wheat flour
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in cognitive abilities
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in iron status indicators
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. John's Research Institute

Collaborators

Ministry of Science and Technology, India
Akzo Nobel

Investigators

  • Principal Investigator: Sumithra Muthayya, PhD, St Johns Research Institute, Sarjapur Road, Bangalore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 23, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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