Zinc Deficiency
Conditions
Keywords
Zinc, deficiency, biofortification, wheat
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBiofortified wheat
Wheat was grown by foliar Zn application and is therefore biofortified
DIETARY_SUPPLEMENTFortification
Wheat flour is fortified before testmeal preparation
DIETARY_SUPPLEMENTControl
wheat flour is used as control comparator.
Sponsors
HarvestPlus
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* generally healthy
Exclusion criteria
* unhealthy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of plasma zinc values from baseline to endpoint and 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 | plasma zinc will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the chronic inflammation marker from baseline to 6 months and 2 month post intervention | day 0, random during the intervention, month 6, and random 2 months post intervention | AGP will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months)and randomly within two months post-intervention |
| Change in Iron status from baseline to the end of the intervention and 2 months post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention | Hb will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention |
| Change in Iron status from baseline to the end of intervention, and within two months post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention | Serum ferritin will be measured at baseline, midpoint (random sparse sampling), endpoint and randomly within two months post-intervention |
| New Zn biomarkers | day 0, random during the intervention, month 6, and random 2 months post intervention | 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 |
| Change in the Inflammation marker from baseline to the end of the intervention, as well as post-intervention | day 0, random during the intervention, month 6, and random 2 months post intervention | CRP will be measured at baseline, midpoint (random sparse sampling), endpoint (end of intervention) and randomly within two months post-intervention |
| Characterization of gut microflora | baseline, endpoint (6 months) | Characterization of microflora will be done in a subsamples of children (taken randomly), at baseline and at the end of feeding (6 months) |
| Anthropometry | baseline (day 0), endpoint (6 months) | anthropometry, such as height, weight will be measured at baseline and endpoint of the study |
| morbidity | throughout the study | morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study |
| New potential Zn biomarkers in buccal cells | day 0, random during the intervention, month 6, and random 2 months post intervention | MT RNA transcript in buccal cells will be measured at baseline, midpoint (random sparse sampling), endpoint |
Countries
India
Outcome results
None listed