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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079583
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : July 22, 2021
Sponsor:
Collaborators:
HarvestPlus
BRAC University
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

Brief Summary:
To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants from a rural area of Bangladesh.

Condition or disease Intervention/treatment Phase
Zinc Deficiency Growth; Stunting, Nutritional Dietary Supplement: Intervention-group Dietary Supplement: Control-group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Zinc-biofortified Rice in Improving Zinc Status in Young Bangladeshi Children, a Double Blind Randomized Controlled Trial
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : April 25, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control-group
Control Rice used for meal, normal zinc level
Dietary Supplement: Control-group
Control Rice with normal zinc levels

Active Comparator: Intervention-group
Biofortified Rice used for meal, around 30% higher zinc level
Dietary Supplement: Intervention-group
Biofortified Rice is grown by foliar Zn application




Primary Outcome Measures :
  1. plasma zinc [ 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). ]
    Change of plasma zinc values from baseline to endpoint and 2 times within study period


Secondary Outcome Measures :
  1. Inflammatory markers [ 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). ]
    C reactive protein (CRP),alpha1-acid glycoprotein (AGP)

  2. Length [ 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). ]
    Length (in cm) measurement for anthropometric (HAZ-scores).

  3. Weight [ 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). ]
    Weight (in kg) measurement for anthropometric (HAZ-scores).

  4. Morbidity [ Time Frame: Fixed assessment once a week for every participant throughout the intervention period (week 1-36). ]
    diarrhea and disease episodes will be recorded weekly throughout the study

  5. FADS analyses [ Time Frame: Secondary analyses of collected plasma samples, in subset of participants (75 children from each group, random selected, matched baseline and endpoint samples) ]
    FADS plasma analyses for zinc biomarker determination

  6. Iron status [ 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). ]
    Plasma ferritin

  7. Iron status [ 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). ]
    Hemoglobin



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079583


Locations
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Bangladesh
BRACU, Bangladesh
Dhaka, Bangladesh
Switzerland
Swiss Federal Institute of Technology (ETH)
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
HarvestPlus
BRAC University
Investigators
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Principal Investigator: Michael B Zimmermann, Prof. Dr. Professor, Laboratory of Human Nutrition, Department of health science and technology, ETH Zurich, Zurich, Switzerland
Principal Investigator: Malay K Mridha, Assoc. Prof. Associate Professor, James P Grant school of Public Health, BRAC University, Dhaka, Bangladesh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT03079583    
Other Study ID Numbers: ZARI_1_trail
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Federal Institute of Technology:
Zinc Biofortification
Zinc Status
Zinc Biomarker
Additional relevant MeSH terms:
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Growth Disorders
Pathologic Processes