NCT03079583

The Efficacy of Zinc-biofortified Rice in Bangladeshi Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Zinc Deficiency
• Growth; Stunting, Nutritional

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intervention-group	Biofortified Rice is grown by foliar Zn application
DIETARY_SUPPLEMENT	Control-group	Control Rice with normal zinc levels

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-04-25
• Completion: 2019-04-25
• First posted: 2017-03-14
• Last updated: 2021-07-22

Locations

2 sites across 2 countries: Bangladesh, Switzerland