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

Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241330
• Other study ID #: EK 2013-N-52
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: April 13, 2016
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• generally healthy

Exclusion Criteria:

• unhealthy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Zinc Deficiency

Intervention

Dietary Supplement:
• Biofortified wheat
Wheat was grown by foliar Zn application and is therefore biofortified
• Fortification
Wheat flour is fortified before testmeal preparation
• Control
wheat flour is used as control comparator.

Locations

Country	Name	City	State
India	St John's Research Institute	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	HarvestPlus

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	day 0, random during the intervention, month 6, and random 2 months post intervention	No
Secondary	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	day 0, random during the intervention, month 6, and random 2 months post intervention	No
Secondary	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	day 0, random during the intervention, month 6, and random 2 months post intervention	No
Secondary	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	day 0, random during the intervention, month 6, and random 2 months post intervention	No
Secondary	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	day 0, random during the intervention, month 6, and random 2 months post intervention	No
Secondary	New potential Zn biomarkers in buccal cells	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	No
Secondary	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)	baseline, endpoint (6 months)	No
Secondary	Anthropometry	anthropometry, such as height, weight will be measured at baseline and endpoint of the study	baseline (day 0), endpoint (6 months)	No
Secondary	morbidity	morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study	throughout the study	No

External Links

•   HarvestPlus website
•   St John's Research Institute website