Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children
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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 |
- change in cognitive abilities [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- 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 |
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| India | |
| St Johns Research Institute | |
| Bangalore, Karnataka, India, 560034 | |
| 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 June 18, 2013