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

April 13, 2016 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
day 0, random between day 0 and 6 month, 6 month and random between 6 months and 2 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
day 0, random during the intervention, month 6, and random 2 months post intervention
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
day 0, random during the intervention, month 6, and random 2 months post intervention
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
day 0, random during the intervention, month 6, and random 2 months post intervention
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)
baseline, endpoint (6 months)
Anthropometry
Time Frame: baseline (day 0), endpoint (6 months)
anthropometry, such as height, weight will be measured at baseline and endpoint of the study
baseline (day 0), endpoint (6 months)
morbidity
Time Frame: throughout the study
morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HarvestPlus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK 2013-N-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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