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Zinc biofortified rice efficacy trial

Efficacy of zinc biofortified rice for preventing zinc deficiency in Bangladesh: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83005630
Enrollment
200
Registered
2024-10-02
Start date
2024-11-14
Completion date
Unknown
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma zinc concentration, among young non-pregnant non-lactating rural women Nutritional, Metabolic, Endocrine

Interventions

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
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 the

Sponsors

Nestlé Foundation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Australia, Bangladesh

Contacts

Public ContactPrasenjit Mondal
prasenjit.mondal@griffithuni.edu.au+88 1673014661

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026