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| ID | Type | Description | Link |
|---|---|---|---|
| BT/PR-8947/FNS/20/325/2007 |
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| Name | Class |
|---|---|
| Akzo Nobel | INDUSTRY |
| Ministry of Science and Technology, India | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Group that receives NaFeEDTA fortified wheat flour |
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| 2 | Placebo Comparator | Unfortified wheat flour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortification of wheat flour with NaFeEdta | Other | NaFeEdta Fortified Wheat Flour (100g)provided as a lunch meal. Fortification level of 6mg Fe/100g/day/child for 7 months |
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| Measure | Description | Time Frame |
|---|---|---|
| change in cognitive abilities | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in iron status indicators | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sumithra Muthayya, PhD | St Johns Research Institute, Sarjapur Road, Bangalore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Johns Research Institute | Bangalore | Karnataka | 560034 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23014487 | Derived | 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. |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
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| ID | Term |
|---|---|
| C019179 | Fe(III)-EDTA |
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| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |