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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741143
• Other study ID #: SJRI-BT-PR-8947
• Secondary ID: BT/PR-8947/FNS/2
• Status: Completed
• Phase: N/A
• First received: August 23, 2008
• Last updated: August 25, 2008
• Start date: August 2007
• Est. completion date: March 2008

Study information

• Verified date: August 2008
• Source: St. John's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cognition
• Deficiency Diseases
• Iron Deficiency
• Iron Deficiency Anemia

Intervention

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

Locations

Country	Name	City	State
India	St Johns Research Institute	Bangalore	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
St. John's Research Institute	Akzo Nobel, Ministry of Science and Technology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cognitive abilities		7 months	No
Secondary	changes in iron status indicators		7 months	No