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Zinc DeficiencyZARINCT03079583

The Efficacy of Zinc-biofortified Rice in Bangladeshi Children

A study testing Intervention-group in people with Zinc Deficiency and Growth; Stunting, Nutritional, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants from a rural area of Bangladesh. Read more about this study

Who is it for?
Ages 12 to 36 monthsHealthy volunteers can take part
What is being tested?
Intervention-group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
520 participants
Where
2 sitesin 2 countries
Study dates
1 Apr 2018to 25 Apr 2019
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 12 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Bangladesh1 site

  • BRACU, Bangladesh

    Dhaka

Other trials in Bangladesh

Switzerland1 site

  • Swiss Federal Institute of Technology (ETH)

    Zurich, 8092

Other trials in Switzerland

About this study

Official title: The Efficacy of Zinc-biofortified Rice in Improving Zinc Status in Young Bangladeshi Children, a Double Blind Randomized Controlled Trial

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

Read the 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.

Being tested
Intervention-group, Control-group
Keywords
Zinc Biofortification, Zinc Status, Zinc Biomarker
Medical subject headings
Growth Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention-groupDietary supplement

    Biofortified Rice is grown by foliar Zn application

  • Control-groupDietary supplement

    Control Rice with normal zinc levels

Study groups in NCT03079583
Study groupRoleWhat they receive
Control-groupPlacebo comparatorControl Rice used for meal, normal zinc level
Receives: Dietary Supplement: Control-group
Intervention-groupActive comparatorBiofortified Rice used for meal, around 30% higher zinc level
Receives: Dietary Supplement: Intervention-group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. plasma zinc

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

    Measured: 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)

  1. Inflammatory markers

    C reactive protein (CRP),alpha1-acid glycoprotein (AGP)

    Measured: 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).

  2. Length

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

    Measured: 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).

  3. Weight

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

    Measured: 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).

  4. Morbidity

    diarrhea and disease episodes will be recorded weekly throughout the study

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

  5. FADS analyses

    FADS plasma analyses for zinc biomarker determination

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

  6. Iron status

    Plasma ferritin

    Measured: 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).

  7. Iron status

    Hemoglobin

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start1 Apr 2018
  3. Primary completion25 Apr 2019
  4. Study completion25 Apr 2019

Resources

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
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079583
Sponsor's protocol ID
ZARI_1_trail
Acronym
ZARI
Status last verified
Jul 2021
First submitted
3 Mar 2017
Last updated
22 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34792094

Questions about this trial

What is this clinical trial studying?

A study testing Intervention-group in people with Zinc Deficiency and Growth; Stunting, Nutritional, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.

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 4 inclusion and 6 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bangladesh, Switzerland. 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?

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).). 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 NCT03079583, 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 22 Jul 2021.

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