Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status: a Randomized Controlled Trial

Conditions
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Zinc Deficiency

Intervention / Treatment
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* Dietary Supplement: Biofortified wheat
* Dietary Supplement: Fortification
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally healthy Exclusion Criteria: unhealthy

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control wheat used for meal, level of zinc is usual | Dietary Supplement: Control<br>* wheat flour is used as control comparator.<br>|
| Active Comparator: fortification<br>Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation | Dietary Supplement: Fortification<br>* Wheat flour is fortified before testmeal preparation<br>|
| Active Comparator: Biofortified<br>Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control | Dietary Supplement: Biofortified wheat<br>* Wheat was grown by foliar Zn application and is therefore biofortified<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheat, Zinc, deficiency, biofortification