Zinc DeficiencyNCT02241330
Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status
A study testing Biofortified wheat and Fortification in people with Zinc Deficiency, run by Swiss Federal Institute of Technology at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- Biofortified wheat and Fortification
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy
Who cannot join
- unhealthy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Zinc Deficiency
- Being tested
- Biofortified wheat, Fortification, Control
- Keywords
- Zinc, deficiency, biofortification, wheat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control wheat used for meal, level of zinc is usual Receives: Dietary Supplement: Control |
| fortification | Active comparator | Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation Receives: Dietary Supplement: Fortification |
| Biofortified | Active comparator | Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control Receives: Dietary Supplement: Biofortified wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
CRP will be measured at baseline, midpoint (random sparse sampling), endpoint (end of intervention) and randomly within two months post-intervention
Measured: 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
Measured: 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
Measured: 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
Measured: day 0, random during the intervention, month 6, and random 2 months post intervention
New Zn biomarkers
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
Measured: day 0, random during the intervention, month 6, and random 2 months post intervention
New potential Zn biomarkers in buccal cells
MT RNA transcript in buccal cells will be measured at baseline, midpoint (random sparse sampling), endpoint
Measured: day 0, random during the intervention, month 6, and random 2 months post intervention
Characterization of gut microflora
Characterization of microflora will be done in a subsamples of children (taken randomly), at baseline and at the end of feeding (6 months)
Measured: baseline, endpoint (6 months)
Anthropometry
anthropometry, such as height, weight will be measured at baseline and endpoint of the study
Measured: baseline (day 0), endpoint (6 months)
morbidity
morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zinc DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- HarvestPlus
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, Prof Dr med, Principal investigator, ETHZAnura V Kurpad, Prof MD PhD, Principal investigator, St John's Research Institute, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241330
- Sponsor's protocol ID
- EK 2013-N-52
- Status last verified
- Apr 2016
- First submitted
- 9 Sep 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37633331
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02241330
- Acronym / sponsor ID
- EK 2013-N-52
- Conditions
- Zinc Deficiency
- Keywords
- Zinc, deficiency, biofortification, wheat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- HarvestPlus
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: ControlControl wheat used for meal, level of zinc is usual |
| fortification | Active comparator | Dietary Supplement: FortificationFortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation |
| Biofortified | Active comparator | Dietary Supplement: Biofortified wheatBiofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- generally healthy
Key exclusion criteria (1 listed)
- unhealthy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofortified wheatWheat was grown by foliar Zn application and is therefore biofortified | Dietary supplement | Biofortified |
| FortificationWheat flour is fortified before testmeal preparation | Dietary supplement | fortification |
| Controlwheat flour is used as control comparator. | Dietary supplement | Control |
Primary outcome
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
9 secondary outcomes
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
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
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
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
New Zn biomarkers
Time frame: 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
Characterization of gut microflora
Time frame: baseline, endpoint (6 months)
Anthropometry
Time frame: baseline (day 0), endpoint (6 months)
morbidity
Time frame: throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 37633331Signorell 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.
- HarvestPlus websiteLink provided by the sponsor.
- St John's Research Institute websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Zimmermann, Prof Dr med principal investigator
ETHZ
Anura V Kurpad, Prof MD PhD principal investigator
St John's Research Institute, Bangalore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofortified wheat and Fortification in people with Zinc Deficiency, run by Swiss Federal Institute of Technology at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02241330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.