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

NCT ID: NCT02241330

Last Updated: 2016-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Control wheat used for meal, level of zinc is usual

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

wheat flour is used as control comparator.

fortification

Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation

Group Type ACTIVE_COMPARATOR

Fortification

Intervention Type DIETARY_SUPPLEMENT

Wheat flour is fortified before testmeal preparation

Biofortified

Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control

Group Type ACTIVE_COMPARATOR

Biofortified wheat

Intervention Type DIETARY_SUPPLEMENT

Wheat was grown by foliar Zn application and is therefore biofortified

Interventions

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Biofortified wheat

Wheat was grown by foliar Zn application and is therefore biofortified

Intervention Type DIETARY_SUPPLEMENT

Fortification

Wheat flour is fortified before testmeal preparation

Intervention Type DIETARY_SUPPLEMENT

Control

wheat flour is used as control comparator.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* generally healthy

Exclusion Criteria

* unhealthy
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HarvestPlus

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael B Zimmermann, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

ETHZ

Anura V Kurpad, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

St John's Research Institute, Bangalore

Locations

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St John's Research Institute

Bangalore, Karnataka, India

Site Status

Countries

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India

References

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Signorell C, Kurpad AV, Pauline M, Shenvi S, Mukhopadhyay A, King JC, Zimmermann MB, Moretti D. The Effect of Zinc Biofortified Wheat Produced via Foliar Application on Zinc Status: A Randomized, Controlled Trial in Indian Children. J Nutr. 2023 Oct;153(10):3092-3100. doi: 10.1016/j.tjnut.2023.08.013. Epub 2023 Aug 25.

Reference Type DERIVED
PMID: 37633331 (View on PubMed)

Related Links

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http://www.harvestplus.org

HarvestPlus website

http://www.sjri.res.in/

St John's Research Institute website

Other Identifiers

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EK 2013-N-52

Identifier Type: -

Identifier Source: org_study_id

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