The Efficacy of Zinc-biofortified Rice in Bangladeshi Children

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT03079583
• Date of registration: 03/03/2017
• Prospective Registration: Yes
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: The Efficacy of Zinc-biofortified Rice in Bangladeshi Children ZARI
• Scientific title: The Efficacy of Zinc-biofortified Rice in Improving Zinc Status in Young Bangladeshi Children, a Double Blind Randomized Controlled Trial
• Date of first enrolment: April 1, 2018
• Target sample size: 520
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03079583
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Bangladesh, Switzerland

Contacts

• Name: Malay K Mridha, Assoc. Prof.
• Affiliation: Associate Professor, James P Grant school of Public Health, BRAC University, Dhaka, Bangladesh

• Name: Michael B Zimmermann, Prof. Dr.
• Affiliation: Professor, Laboratory of Human Nutrition, Department of health science and technology, ETH Zurich, Zurich, Switzerland

Key inclusion & exclusion 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).



Age minimum: 12 Months
Age maximum: 36 Months
Gender: All

Health Condition(s) or Problem(s) studied

Growth; Stunting, Nutritional

Zinc Deficiency

Intervention(s)

Dietary Supplement: Intervention-group

Dietary Supplement: Control-group

Primary Outcome(s)

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).]

Secondary Outcome(s)

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)]

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).]

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).]

Morbidity [Time Frame: Fixed assessment once a week for every participant throughout the intervention period (week 1-36).]

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).]

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).]

Secondary ID(s)

ZARI_1_trail

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BRAC University

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