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| Name | Class |
|---|---|
| HarvestPlus | OTHER |
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The objective of this research is to test the efficacy of Zn biofortified wheat in increasing Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Control wheat used for meal, level of zinc is usual |
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| fortification | Active Comparator | Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation |
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| Biofortified | Active Comparator | Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofortified wheat | Dietary Supplement | Wheat was grown by foliar Zn application and is therefore biofortified |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of plasma zinc values from baseline to endpoint and two months post intervention | plasma zinc will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention | day 0, random between day 0 and 6 month, 6 month and random between 6 months and 2 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Inflammation marker from baseline to the end of the intervention, as well as post-intervention | CRP will be measured at baseline, midpoint (random sparse sampling), endpoint (end of intervention) and randomly within two months post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Zimmermann, Prof Dr med | ETHZ | Principal Investigator |
| Anura V Kurpad, Prof MD PhD | St John's Research Institute, Bangalore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St John's Research Institute | Bangalore | Karnataka | 460034 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37633331 | Derived | Signorell C, Kurpad AV, Pauline M, Shenvi S, Mukhopadhyay A, King JC, Zimmermann MB, Moretti D. The Effect of Zinc Biofortified Wheat Produced via Foliar Application on Zinc Status: A Randomized, Controlled Trial in Indian Children. J Nutr. 2023 Oct;153(10):3092-3100. doi: 10.1016/j.tjnut.2023.08.013. Epub 2023 Aug 25. |
| Label | URL |
|---|---|
| HarvestPlus website | View source |
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| Fortification | Dietary Supplement | Wheat flour is fortified before testmeal preparation |
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| Control | Dietary Supplement | wheat flour is used as control comparator. |
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| Change in the chronic inflammation marker from baseline to 6 months and 2 month post intervention | AGP will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months)and randomly within two months post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention |
| Change in Iron status from baseline to the end of the intervention and 2 months post-intervention | Hb will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention |
| Change in Iron status from baseline to the end of intervention, and within two months post-intervention | Serum ferritin will be measured at baseline, midpoint (random sparse sampling), endpoint and randomly within two months post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention |
| New Zn biomarkers | new potential zn biomarkers will be measured in whole blood and plasma at baseline, midpoint (random sparse sampling), endpoint and randomly within two months post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention |
| New potential Zn biomarkers in buccal cells | MT RNA transcript in buccal cells will be measured at baseline, midpoint (random sparse sampling), endpoint | day 0, random during the intervention, month 6, and random 2 months post intervention |
| Characterization of gut microflora | Characterization of microflora will be done in a subsamples of children (taken randomly), at baseline and at the end of feeding (6 months) | baseline, endpoint (6 months) |
| Anthropometry | anthropometry, such as height, weight will be measured at baseline and endpoint of the study | baseline (day 0), endpoint (6 months) |
| morbidity | morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study | throughout the study |
| St John's Research Institute website | View source |