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

Swiss Federal Institute of Technology284 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

284

Conditions

Zinc Deficiency

Interventions

Biofortified wheatDIETARY_SUPPLEMENT

Wheat was grown by foliar Zn application and is therefore biofortified

FortificationDIETARY_SUPPLEMENT

Wheat flour is fortified before testmeal preparation

ControlDIETARY_SUPPLEMENT

wheat flour is used as control comparator.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * generally healthy Exclusion Criteria: * unhealthy

Locations (1)

St John's Research Institute

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

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

Time frame: day 0, random between day 0 and 6 month, 6 month and random between 6 months and 2 months post-intervention

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: day 0, random during the intervention, month 6, and random 2 months post intervention

Data from ClinicalTrials.gov

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