Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status
- Conditions
- Zinc Deficiency
- Interventions
- Dietary Supplement: Biofortified wheatDietary Supplement: FortificationDietary Supplement: Control
- Registration Number
- NCT02241330
- Lead Sponsor
- Swiss Federal Institute of Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 284
- generally healthy
- unhealthy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biofortified Biofortified wheat Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control fortification Fortification Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation Control Control Control wheat used for meal, level of zinc is usual
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
Trial Locations
- Locations (1)
St John's Research Institute
🇮🇳Bangalore, Karnataka, India