Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children
NCT ID: NCT00741143
Last Updated: 2008-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
194 participants
INTERVENTIONAL
2007-08-31
2008-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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1
Group that receives NaFeEDTA fortified wheat flour
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
2
Unfortified wheat flour
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
7 Years
15 Years
ALL
Yes
Sponsors
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Akzo Nobel
INDUSTRY
Ministry of Science and Technology, India
OTHER_GOV
St. John's Research Institute
OTHER
Responsible Party
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St Johns Research Institute
Principal Investigators
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Sumithra Muthayya, PhD
Role: PRINCIPAL_INVESTIGATOR
St Johns Research Institute, Sarjapur Road, Bangalore
Locations
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St Johns Research Institute
Bangalore, Karnataka, India
Countries
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References
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Muthayya S, Thankachan P, Hirve S, Amalrajan V, Thomas T, Lubree H, Agarwal D, Srinivasan K, Hurrell RF, Yajnik CS, Kurpad AV. Iron fortification of whole wheat flour reduces iron deficiency and iron deficiency anemia and increases body iron stores in Indian school-aged children. J Nutr. 2012 Nov;142(11):1997-2003. doi: 10.3945/jn.111.155135. Epub 2012 Sep 26.
Other Identifiers
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BT/PR-8947/FNS/20/325/2007
Identifier Type: -
Identifier Source: secondary_id
SJRI-BT-PR-8947
Identifier Type: -
Identifier Source: org_study_id