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Zinc Absorption From Zinc Biofortified Rice in Bangladeshi Children

Primary Purpose

Malnourished Children

Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Diet-ZnBfR: Zinc biofortified rice-based diet
Diet- CR: Conventional rice-based diet
CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z).
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Malnourished Children focused on measuring Rice, biofortification,, Bangladeshi children, zinc

Eligibility Criteria

36 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Not meeting the inclusion criteria.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
September 20, 2019
Last Updated
April 12, 2022
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04099849
Brief Title
Zinc Absorption From Zinc Biofortified Rice in Bangladeshi Children
Official Title
Absorption of Zinc From Mixed Diets Containing Conventional Bangladeshi Rice, Zinc-biofortified Bangladeshi Rice, or Conventional Bangladeshi Rice With Added Zinc Among Young Children From a Peri-urban Community
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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. Objectives: 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. To assess the intestinal function of the children, using a sugar permeability test (lactulose:mannitol test). (Pilot study) To verify that the modified tracer dose will provide adequate signal for assessing zinc absorption. Methods: To assess the potentials for biofortified rice in providing a good, bioavailable source of additional zinc, it is proposed here to measure zinc absorption from rice-based meals among Bangladeshi preschool children. The amount of zinc absorbed from ZnBfR compared to that absorbed from a conventional Bangladeshi rice (Diet-CR) (control) will be measured. Zinc absorbed from ZnBfR with that from zinc-fortified conventional rice (Diet-CR+Z) will also be compared. The study will be a cross-over, randomized, controlled clinical study. Initially, a pilot study will be conducted with a modified dose of zinc stable isotope among 4 children aged 36-59 months of either sex from a peri-urban community in Dhaka. Later on, 44 children aged 36-59 months of either sex will be recruited from the same community as mentioned before, and they will be individually randomized, in equal numbers, to one of the two comparison groups, A and B. During an initial one-day acclimatization period, the study children will receive the conventional rice based diet three times a day, to confirm that they will accept the study diets and adhere to the study procedures. On study days 2 and 4, in comparison group A, the study subjects will receive either the Diet-ZnBfR or Diet-CR based on the random assignments, and they will receive Diet-CR or Diet ZnBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4), Likewise, in comparison group B, the study subjects will receive either Diet-ZnBfR or Diet-CR+Z on days 2 and 4 based on the random assignments, and they will receive Diet-CR+Z or the Diet-ZnBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4). Zinc stable isotope tracer techniques will be used to measure the fractional absorption of zinc, in which tracer : tracee ratios will be measured in spot urine samples following administration of an intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided with test meals over a four-day period. Outcome measures/variables: Intake of total dietary zinc (TDZ) and phytate for each subject will be calculated during the clinical study. Fractional absorption of zinc (FAZ) will be determined from the isotopic ratios obtained in urine samples using the following equation, which shows, as an example, the calculation that will be used for zinc absorption from the diet traced with 67Zn: FAZ = 67Zn tracer:tracee ratio / 68Zn tracer:tracee ratio * (68Zn dose given IV / 67Zn dose given orally) Total absorbed zinc (TAZ) for each child will be calculated as follows: TAZ (mg/d) = TDZ (mg/d) * FAZ

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnourished Children
Keywords
Rice, biofortification,, Bangladeshi children, zinc

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Diet-ZnBfR zinc biofortified rice-based diet Diet- CR conventional rice-based diet
Arm Title
Group B
Arm Type
Experimental
Arm Description
Diet-ZnBfR zinc biofortified rice-based diet CR + Zn conventional rice-based diet plus zinc fortificant (Diet-CR+Z).
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet-ZnBfR: Zinc biofortified rice-based diet
Intervention Description
Diet-ZnBfR: Zinc biofortified rice-based diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet- CR: Conventional rice-based diet
Intervention Description
Diet- CR: Conventional rice-based diet
Intervention Type
Dietary Supplement
Intervention Name(s)
CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z).
Intervention Description
CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z).
Primary Outcome Measure Information:
Title
Total absorbed zinc
Description
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)
Time Frame
13 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Not meeting the inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Md Munirul Islam, PhD
Phone
+880-2-9827001-10
Ext
2352
Email
mislam@icddrb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tahmeed Ahmed, PhD
Phone
+880-2-9827001-10
Ext
2300
Email
tahmeed@icddrb.org
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research , Bangladesh (icddr,b)
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Md Munirul Islam, PhD
Phone
+88029827001-10
Ext
2352
Email
mislam@icddrb.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Zinc Absorption From Zinc Biofortified Rice in Bangladeshi Children

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