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

This study has been completed.
Sponsor:
Collaborators:
Akzo Nobel
Ministry of Science and Technology, India
Information provided by:
St. John's Research Institute
ClinicalTrials.gov Identifier:
NCT00741143
First received: August 23, 2008
Last updated: August 25, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Iron Deficiency
Iron Deficiency Anemia
Cognition
Other: Fortification of wheat flour with NaFeEdta

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children

Resource links provided by NLM:


Further study details as provided by St. John's Research Institute:

Primary Outcome Measures:
  • change in cognitive abilities [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in iron status indicators [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741143

Locations
India
St Johns Research Institute
Bangalore, Karnataka, India, 560034
Sponsors and Collaborators
St. John's Research Institute
Akzo Nobel
Ministry of Science and Technology, India
Investigators
Principal Investigator: Sumithra Muthayya, PhD St Johns Research Institute, Sarjapur Road, Bangalore
  More Information

No publications provided by St. John's Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Sumithra Muthayya, St Johns Research Institute
ClinicalTrials.gov Identifier: NCT00741143     History of Changes
Other Study ID Numbers: SJRI-BT-PR-8947, BT/PR-8947/FNS/20/325/2007
Study First Received: August 23, 2008
Last Updated: August 25, 2008
Health Authority: India: Institutional Review Board

Keywords provided by St. John's Research Institute:
Food Fortification
Iron deficiency
NaFeEdta
Iron deficiency anemia
Cognition

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Fe(III)-EDTA
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014