Zinc biofortified rice efficacy trial

ISRCTN	ISRCTN83005630
DOI	https://doi.org/10.1186/ISRCTN83005630
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Griffith University IRB Ref No: 2023/611
Sponsor	Nestlé Foundation
Funder	Fondation Nestlé

Submission date: 26/09/2024
Registration date: 02/10/2024
Last edited: 10/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Zinc deficiency is common among women and children in low- and middle-income countries (LMICs) due to their plant-based diets, which lack zinc and contain factors that prevent zinc absorption. To address this, we are testing zinc biofortified rice as a potential solution. Previous studies with biofortified crops like wheat, rice, and pearl millet did not show significant improvements in zinc levels. Therefore, we are conducting a community-based randomized controlled trial to test the effectiveness of zinc-biofortified rice in improving zinc status among young women in rural Bangladesh.

Who can participate?
Young non-pregnant, non-lactating (NPNL) women aged 20 to 29 years living in the rural area of Birganj, Dinajpur in Bangladesh can participate in this study.

What does the study involve?
Participants will be divided into two groups. One group will receive high-zinc biofortified rice (ZBR) for themselves and their families for three months. The other group will receive low-zinc conventional rice (CR) for the same period. We will conduct surveys at the beginning and end of the study to collect data on health and diet, and blood samples will be taken to measure zinc levels and other health markers. We will also test the rice for zinc content before and after cooking.

What are the possible benefits and risks of participating?
Participants will receive a supply of rice for their families for three months and will get their blood test results. The study poses minimal risk, with the main discomfort being blood sample collection. All precautions will be taken to ensure safety. The study’s findings could help policymakers promote zinc-biofortified rice, benefiting the wider population.

Where is the study run from?
The study is being conducted by Griffith University in Queensland, Australia, in partnership with BRAC James P Grant School of Public Health, BRAC University in Bangladesh.

When is the study starting and how long is it expected to run for?
August 2023 to March 2025

Who is funding the study?
Nestle Foundation (Switzerland)

Who is the main contact?
Dr Faruk Ahmed, f.ahmed@griffith.edu.au

Contact information

Prof Faruk Ahmed
Scientific, Principal investigator

Building G01, Room: 3.42
Griffith University
Gold Coast
4222
Australia

Phone	+61 756787874
Email	f.ahmed@griffith.edu.au

Mr Prasenjit Mondal
Public

Graduate Research Assistant, BRAC James P Grant School of Public Health, BRAC University, 65, Bir Uttam AK Khandakar Road, Mohakhali
Dhaka
1212
Bangladesh

ORCID ID	0000-0002-8340-4101
Phone	+88 1673014661
Email	prasenjit.mondal@griffithuni.edu.au

Dr Sabuktagin Rahman
Scientific

Associate Professor, Faculty of Arts and Social Sciences, American International University-Bangladesh (AIUB), 408/1 (Old KA 66/1), Kuratoli, Khilkhet
Dhaka
1229
Bangladesh

Phone	+88 1714102633
Email	rahman.sabuktagin@gmail.com

Study information

Primary study design	Interventional
Study design	Community-based interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN83005630_PIS.pdf
Scientific title	Efficacy of zinc biofortified rice for preventing zinc deficiency in Bangladesh: a randomized controlled trial
Study objectives	The study hypothesizes that consuming zinc-biofortified rice for three months is going to improve zinc status, measured by plasma zinc concentration, among young non-pregnant non-lactating rural women (aged between 20-29 years) in rural Bangladesh compared to consumption of low-zinc conventional rice for the same duration.
Ethics approval(s)	1. Approved 25/08/2023, Human Research Ethics Committee (EC00162) (Research Ethics and Integrity, Office for Research, Bray Centre (N54), Nathan Campus, Griffith University, Brisbane, 4111, Australia; +61 737352069; research-ethics@griffith.edu.au), ref: 2023/611 2. Approved 03/06/2024, Institutional Review Board, BRAC James P Grant School of Public Health, BRAC University (65, Bir Uttam AK Khandakar Road, Mohakhali, Dhaka, 1212, Bangladesh; +88-2-48812213-18; irb-jpgsph@bracu.ac.bd), ref: IRB-2024-IS-08
Health condition(s) or problem(s) studied	Plasma zinc concentration, among young non-pregnant non-lactating rural women
Intervention	This will be a community-based randomized controlled trial where the participants will be assigned into two arms, using simple random sampling. participants in the intervention arm will receive a raw rice supply of zinc-biofortified rice (ZBR; BRRI-100 variety) for three months for themselves and their family members, and participants in the control arm will receive a raw rice supply of low-zinc conventional rice (CR) for themselves and their family members for the same duration. The participants are asked to consume the supplied rice ad libitum along with their habitual diet (other food items except rice). Baseline and endline surveys will be carried out to detect the difference in plasma zinc concentration among the study participants and determine the treatment effect. Compliance will be monitored, and dietary intake will be assessed to estimate zinc intake during the study period.
Intervention type	Other
Primary outcome measure(s)	Plasma zinc concentration, measured from plasma sample collected at baseline and 3 months (endline) analysed by atomic absorption spectrometry. The value will be further adjusted for serum C-reactive Protein (CRP) and alpha-1 acid glycoprotein (AGP) which will be measured from serum using commercial ELISA kits at similar timepoints.
Key secondary outcome measure(s)	Current secondary outcome measures as of 07/10/2024: 1. Zinc deficiency measured as the fraction of participants having a PZC level below the cutoff of the normal range provided by the International Zinc Nutrition Consultative Group (IZiNCG) for the age and sex of the individual. The outcome will be measured at baseline and 3 months (endline). 2. Morbidity measured by the frequency and duration of common morbidities such as fever, diarrhoea, sore throat, cold and cough, body pain, and vomiting. The data will be collected at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks (3 months, endline) from the participants (self-report), converted into longitudinal prevalence (LP) and compared between two arms. Previous secondary outcome measures: 1. Zinc deficiency measured as the fraction of participants having a PZC level below the cutoff of the normal range provided by the International Zinc Nutrition Consultative Group (IZiNCG) for the age and sex of the individual. The outcome will be measured at baseline and 3 months (endline). 2. Morbidity measured by the frequency and duration of common morbidities such as fever, diarrhoea, sore throat, cold and cough, body pain, and vomiting. The data will be collected from the participants (self-report) at baseline and 3 months (endline).
Completion date	31/03/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	20 Years
Upper age limit	29 Years
Sex	Female
Target sample size at registration	200
Total final enrolment	197
Key inclusion criteria	1. Healthy non-pregnant, non-lactating women aged between 20 and 29 years. 2. Residing in the study area and intending to live there for the next six months. 3. Did not consume any micronutrient supplementation (including iron folic acid supplementation) in the preceding 3 months. 4. Not recipients of ration from any government safety net programs. 5. Willing to participate in the study.
Key exclusion criteria	1. Participants having any acute, sub-acute or chronic condition that prevents them from complying with the study procedure. 2. Participants whose families are recipients of ration from any government social safety net program.
Date of first enrolment	14/11/2024
Date of final enrolment	30/11/2024

Locations

Countries of recruitment

Australia
Bangladesh

Study participating centres

BRAC James P Grant School of Public Health, BRAC University

65, Bir Uttam AK Khandakar Road, Mohakhali
Dhaka
1212
Bangladesh

Griffith University

1 Parklands Dr, Southport QLD
Gold Coast
4215
Australia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Available on request
IPD sharing plan	IPD will be stored on a non-publicly available repository and will be made available on request. All data will be deidentified while being entered into a secure electronic database in a computer server at Griffith University Research Storage Platform (https://research-storage.griffith.edu.au/).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			29/11/2024	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN83005630_PIS.pdf: Participant information sheet

Editorial Notes

10/01/2025: Total final enrolment added.
29/11/2024: The following updates were made:
1. Participant information sheet added.
2. The recruitment start date was changed from 01/11/2024 to 14/11/2024.
07/10/2024: The secondary outcome measures were updated.
04/10/2024: The intervention duration was changed from two months to three months in the plan English summary, study hypothesis, interventions and outcome measures.
26/09/2024: Trial's existence confirmed by Nestle Foundation.