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

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

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.

Study Overview

• Status: Completed
• Conditions: Zinc Deficiency
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Fortification; Dietary supplement: Biofortified wheat

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 460034
      • St John's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• generally healthy

Exclusion Criteria:

• unhealthy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: HarvestPlus
• Investigators: Principal Investigator: Michael B Zimmermann, Prof Dr med, ETHZ; Principal Investigator: Anura V Kurpad, Prof MD PhD, St John's Research Institute, Bangalore

Publications and helpful links

Helpful Links

• Human Nutrition Laboratory ETHZ
• HarvestPlus website
• St John's Research Institute website

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Zinc; deficiency; biofortification; wheat
• Other Study ID Numbers: EK 2013-N-52