Zinc Absorption From Zinc Biofortified Rice in Bangladeshi Children

NCT04099849 | Unknown

• 1 other identifier: PR-13008
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

It is well documented that zinc supplementation to low-income population results in the reduced incidence of childhood diarrhoea and pneumonia, and improves growth of stunted children. In Bangladesh, the risk of zinc deficiency is considered to be high and children could benefit greatly by improving their zinc intakes on a daily basis. Zinc supplementation at a national scale would be a formidable task. There is a need to find an alternative. It might be sustainable to improve intake of zinc through fortified staples, e.g. rice with increased amounts of zinc; in fact such biofortified rice has been developed through conventional breeding, which is designed to contain an amount of zinc that could meet at least 40% of the daily requirement. In the first round of the previously approved and completed studies, total absorbed zinc (TAZ) did not differ when diets containing zinc biofortified rice (ZnBfR) or conventional rice (CR) were compared. Thus, the current study is planned to repeat using a new variety of (ZnBfR) that is expected to have higher zinc content than the variety previously studied. Initially, a pilot study will be conducted in 4 participants using a modified isotope administration protocol such that the oral tracers will be given on two days each at half the original dose each day so as to provide a lower proportion of the total daily zinc intake as tracer solution. Hypotheses:

1. 1.Young children will have greater total absorbed zinc (TAZ) when they consume mixed diets containing ZnBfR than when they consume the same diets containing CR.
2. 2.TAZ will not differ in children who receive the ZnBfR-containing diet or the same diet containing CR plus sufficient additional zinc to match the zinc content of the ZnBfR diet.
3. 3.To measure the amount of zinc absorbed from ZnBfR compared with the amount absorbed from CR and from CR fortified with added zinc, using the triple stable isotope tracer ratio technique in young children.
4. 4.To assess the intestinal function of the children, using a sugar permeability test (lactulose:mannitol test).
5. 5.(Pilot study) To verify that the modified tracer dose will provide adequate signal for assessing zinc absorption.

Conditions

Malnourished Children

Keywords

Rice; biofortification,; Bangladeshi children; zinc

Outcome Measures

Primary Outcomes (1)

• Total absorbed zinc

  Total absorbed zinc (TAZ) for each child will be calculated as follows: TAZ (mg/d) = Total Dietray Zinc (TDZ) (mg/d) \* Frcational Absorbed Zinc (FAZ)

  13 days

Study Arms (2)

Group A

EXPERIMENTAL

Diet-ZnBfR zinc biofortified rice-based diet Diet- CR conventional rice-based diet

Dietary Supplement: Diet-ZnBfR: Zinc biofortified rice-based diet; Dietary Supplement: Diet- CR: Conventional rice-based diet

Group B

EXPERIMENTAL

Diet-ZnBfR zinc biofortified rice-based diet CR + Zn conventional rice-based diet plus zinc fortificant (Diet-CR+Z).

Dietary Supplement: Diet-ZnBfR: Zinc biofortified rice-based diet; Dietary Supplement: CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z).

Interventions

Diet-ZnBfR: Zinc biofortified rice-based diet DIETARY_SUPPLEMENT

Diet-ZnBfR: Zinc biofortified rice-based diet

Group A; Group B

Diet- CR: Conventional rice-based diet DIETARY_SUPPLEMENT

Diet- CR: Conventional rice-based diet

Group A

CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z). DIETARY_SUPPLEMENT

CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z).

Group B

Eligibility Criteria

• Age: 36 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Weight for Height Z-Score (WHZ) and Height for Age (HAZ): \>-2 Z-Score
• No longer breastfed
• No H/O diarrhoea in last 14 days
• Given anti-helminthics in last three months

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

International Centre for Diarrhoeal Disease Research , Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

RECRUITING

Central Study Contacts

Md Munirul Islam, PhD

CONTACT

+880-2-9827001-10; mislam@icddrb.org

Tahmeed Ahmed, PhD

CONTACT

+880-2-9827001-10; tahmeed@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 23, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-01

Locations

BA (1)