NCT02241330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

September 9, 2014

Last Update Submit

April 13, 2016

Conditions

Zinc Deficiency

Keywords

Zincdeficiencybiofortificationwheat

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • New Zn biomarkers

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

  • +4 more secondary outcomes

Study Arms (3)

Control

PLACEBO COMPARATOR

Control wheat used for meal, level of zinc is usual

Dietary Supplement: Control

fortification

ACTIVE COMPARATOR

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

Dietary Supplement: Fortification

Biofortified

ACTIVE COMPARATOR

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

Dietary Supplement: Biofortified wheat

Interventions

Biofortified wheatDIETARY_SUPPLEMENT

Wheat was grown by foliar Zn application and is therefore biofortified

Biofortified
FortificationDIETARY_SUPPLEMENT

Wheat flour is fortified before testmeal preparation

fortification
ControlDIETARY_SUPPLEMENT

wheat flour is used as control comparator.

Control

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • generally healthy

You may not qualify if:

  • unhealthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St John's Research Institute

Bangalore, Karnataka, 460034, India

Location

Related Publications (1)

  • 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.

    PMID: 37633331DERIVED

Related Links

Study Officials

  • Michael B Zimmermann, Prof Dr med

    ETHZ

    PRINCIPAL INVESTIGATOR

  • Anura V Kurpad, Prof MD PhD

    St John's Research Institute, Bangalore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 16, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

IN(1)