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The Efficacy of Zinc-biofortified Rice in Bangladeshi Children (ZARI)

Primary Purpose

Zinc Deficiency, Growth; Stunting, Nutritional

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention-group
Control-group
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Zinc Deficiency focused on measuring Zinc Biofortification, Zinc Status, Zinc Biomarker

Eligibility Criteria

12 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 12-36 months of age (at baseline assessment)
  • Low plasma Zn concentration (<10.71 µmol/L)
  • Marginally stunted (height for age Z-score <-1.75)
  • The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)

Exclusion Criteria:

  • Severe Anemia (Hb< 70 g/L)
  • Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would affect Zn metabolism or would render the participant unable to comply with the protocol (based on self-reporting or diagnosed during screening)
  • Participants taking part in other studies requiring the drawing of blood
  • Not planning long-term residence in study site
  • Regular intake (>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months
  • Chronic use of drugs that affect the metabolism of Zn, including reducing absorption or increasing excretion; e.g., tuberculosis medications (ethambutal and isoniazides), drugs used as treatment for entamoeba hystolica (diiodohydroxyquin), drugs that reduce stomach acidity (H2 blockers and proton pump inhibitory), antidepressants (nialamide and socarboxazid), anti-inflammatory drugs (corticosteroids), diuretics (thiazides).

Sites / Locations

  • BRACU, Bangladesh
  • Swiss Federal Institute of Technology (ETH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control-group

Intervention-group

Arm Description

Control Rice used for meal, normal zinc level

Biofortified Rice used for meal, around 30% higher zinc level

Outcomes

Primary Outcome Measures

plasma zinc
Change of plasma zinc values from baseline to endpoint and 2 times within study period

Secondary Outcome Measures

Inflammatory markers
C reactive protein (CRP),alpha1-acid glycoprotein (AGP)
Length
Length (in cm) measurement for anthropometric (HAZ-scores).
Weight
Weight (in kg) measurement for anthropometric (HAZ-scores).
Morbidity
diarrhea and disease episodes will be recorded weekly throughout the study
FADS analyses
FADS plasma analyses for zinc biomarker determination
Iron status
Plasma ferritin
Iron status
Hemoglobin

Full Information

First Posted
March 3, 2017
Last Updated
July 16, 2021
Sponsor
Swiss Federal Institute of Technology
Collaborators
HarvestPlus, BRAC University
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1. Study Identification

Unique Protocol Identification Number
NCT03079583
Brief Title
The Efficacy of Zinc-biofortified Rice in Bangladeshi Children
Acronym
ZARI
Official Title
The Efficacy of Zinc-biofortified Rice in Improving Zinc Status in Young Bangladeshi Children, a Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
HarvestPlus, BRAC University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants from a rural area of Bangladesh.
Detailed Description
Rationale: Around the world and estimated 30% of the population is at risk of Zinc deficiency, mainly due to monotonous plant base diets and the poor bioavailability of this sources. One staple food crop which is low in zinc content is rice. Therefore, zinc deficiency is highly common in Asia. Zinc plays a major role in child growth and neurobehavioral development. Furthermore, it is linked to infection control and normal immune response. One way to add extra zinc to someone's diet is zinc bio fortification of staple crops, which can be a cost saving sustainable approach to improve zinc nutrition. However, data on long-term intake of biofortified crops with zinc is scarce and efficacy of newly developed rice crops high in zinc are not well known. Objective: The objective is to assess the efficacy of a newly developed zinc biofortified rice variety on plasma zinc concentrations in children in a rural area of Bangladesh when compared to their controls in a 9 month randomized controlled trial (RCT). Study design: A double randomized control trial. Study population: Stunted children whom are zinc deficient at start of the study intervention determined by plasma zinc levels <9.9 µmol/L. Main study parameters/endpoints: The difference in zinc status between the intervention and control group expressed in blood plasma zinc levels. Plasma zinc will be measured 4 times during the intervention period. Besides plasma zinc other zinc biomarkers will be tested for their usefulness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zinc Deficiency, Growth; Stunting, Nutritional
Keywords
Zinc Biofortification, Zinc Status, Zinc Biomarker

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control-group
Arm Type
Placebo Comparator
Arm Description
Control Rice used for meal, normal zinc level
Arm Title
Intervention-group
Arm Type
Active Comparator
Arm Description
Biofortified Rice used for meal, around 30% higher zinc level
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention-group
Intervention Description
Biofortified Rice is grown by foliar Zn application
Intervention Type
Dietary Supplement
Intervention Name(s)
Control-group
Intervention Description
Control Rice with normal zinc levels
Primary Outcome Measure Information:
Title
plasma zinc
Description
Change of plasma zinc values from baseline to endpoint and 2 times within study period
Time Frame
4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3).
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
C reactive protein (CRP),alpha1-acid glycoprotein (AGP)
Time Frame
4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3).
Title
Length
Description
Length (in cm) measurement for anthropometric (HAZ-scores).
Time Frame
4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3).
Title
Weight
Description
Weight (in kg) measurement for anthropometric (HAZ-scores).
Time Frame
4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3).
Title
Morbidity
Description
diarrhea and disease episodes will be recorded weekly throughout the study
Time Frame
Fixed assessment once a week for every participant throughout the intervention period (week 1-36).
Title
FADS analyses
Description
FADS plasma analyses for zinc biomarker determination
Time Frame
Secondary analyses of collected plasma samples, in subset of participants (75 children from each group, random selected, matched baseline and endpoint samples)
Title
Iron status
Description
Plasma ferritin
Time Frame
4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3).
Title
Iron status
Description
Hemoglobin
Time Frame
4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 12-36 months of age (at baseline assessment) Low plasma Zn concentration (<10.71 µmol/L) Marginally stunted (height for age Z-score <-1.75) The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy) Exclusion Criteria: Severe Anemia (Hb< 70 g/L) Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would affect Zn metabolism or would render the participant unable to comply with the protocol (based on self-reporting or diagnosed during screening) Participants taking part in other studies requiring the drawing of blood Not planning long-term residence in study site Regular intake (>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months Chronic use of drugs that affect the metabolism of Zn, including reducing absorption or increasing excretion; e.g., tuberculosis medications (ethambutal and isoniazides), drugs used as treatment for entamoeba hystolica (diiodohydroxyquin), drugs that reduce stomach acidity (H2 blockers and proton pump inhibitory), antidepressants (nialamide and socarboxazid), anti-inflammatory drugs (corticosteroids), diuretics (thiazides).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Zimmermann, Prof. Dr.
Organizational Affiliation
Professor, Laboratory of Human Nutrition, Department of health science and technology, ETH Zurich, Zurich, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Malay K Mridha, Assoc. Prof.
Organizational Affiliation
Associate Professor, James P Grant school of Public Health, BRAC University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
BRACU, Bangladesh
City
Dhaka
Country
Bangladesh
Facility Name
Swiss Federal Institute of Technology (ETH)
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34792094
Citation
Jongstra R, Hossain MM, Galetti V, Hall AG, Holt RR, Cercamondi CI, Rashid SF, Zimmermann MB, Mridha MK, Wegmueller R. The effect of zinc-biofortified rice on zinc status of Bangladeshi preschool children: a randomized, double-masked, household-based, controlled trial. Am J Clin Nutr. 2022 Mar 4;115(3):724-737. doi: 10.1093/ajcn/nqab379.
Results Reference
derived

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The Efficacy of Zinc-biofortified Rice in Bangladeshi Children

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