Skip to main content
OpenTrials
Completed

NCT Number: NCT02241330

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Zinc Deficiency

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St John's Research Institute

Bangalore, Karnataka, 460034, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • generally healthy

Exclusion criteria

  • unhealthy

Treatment and study plan

Biofortified wheat

Dietary Supplement

Wheat was grown by foliar Zn application and is therefore biofortified

Fortification

Dietary Supplement

Wheat flour is fortified before testmeal preparation

Control

Dietary Supplement

wheat flour is used as control comparator.

Primary outcomes

  1. Change of plasma zinc values from baseline to endpoint and 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

    plasma zinc will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention

Secondary outcomes

  1. Change in the Inflammation marker from baseline to the end of the intervention, as well as post-intervention

    Time frame: 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

  2. Change in the chronic inflammation marker from baseline to 6 months and 2 month post intervention

    Time frame: 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

  3. Change in Iron status from baseline to the end of the intervention and 2 months post-intervention

    Time frame: 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

  4. Change in Iron status from baseline to the end of intervention, and within two months post-intervention

    Time frame: 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

  5. New Zn biomarkers

    Time frame: 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

  6. New potential Zn biomarkers in buccal cells

    Time frame: 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

  7. Characterization of gut microflora

    Time frame: 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)

  8. Anthropometry

    Time frame: baseline (day 0), endpoint (6 months)

    anthropometry, such as height, weight will be measured at baseline and endpoint of the study

  9. morbidity

    Time frame: throughout the study

    morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • HarvestPlus

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2014
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.