The Efficacy of Zinc-biofortified Rice in Bangladeshi Children

NCT03079583 | Completed DMC

• 1 other identifier: ZARI_1_trail
• Study Type: interventional
• Target: 520
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Zinc Deficiency; Growth; Stunting, Nutritional

Keywords

Zinc Biofortification; Zinc Status; Zinc Biomarker

Outcome Measures

Primary Outcomes (1)

• plasma zinc

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

  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 Outcomes (7)

• Inflammatory markers

  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

  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

  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).

• Morbidity

  Fixed assessment once a week for every participant throughout the intervention period (week 1-36).

• FADS analyses

  Secondary analyses of collected plasma samples, in subset of participants (75 children from each group, random selected, matched baseline and endpoint samples)

Study Arms (2)

Control-group

PLACEBO COMPARATOR

Control Rice used for meal, normal zinc level

Dietary Supplement: Control-group

Intervention-group

ACTIVE COMPARATOR

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

Dietary Supplement: Intervention-group

Interventions

Intervention-group DIETARY_SUPPLEMENT

Biofortified Rice is grown by foliar Zn application

Intervention-group

Control-group DIETARY_SUPPLEMENT

Control Rice with normal zinc levels

Control-group

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• HarvestPlus: collaborator
• BRAC University: collaborator

Study Sites (2)

BRACU, Bangladesh

Dhaka, Bangladesh

Location

Swiss Federal Institute of Technology (ETH)

Zurich, 8092, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34792094 DERIVED

MeSH Terms

Conditions

Growth Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 14, 2017
• Study Start: April 1, 2018
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1); CH (1)