NCT01346722

Brief Summary

a. 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. Methods: Investigators will measure the amount of zinc absorbed from ZnBfR compared to that absorbed from a conventional Bangladeshi rice (Diet-CR) (control). They will also compare the zinc absorption from ZnBfR with that from zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized, controlled clinical study. Forty-four children aged 36-59 mo of either sex will be recruited from the same community as mentioned before, and participants 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 participants will receive the conventional rice-based diet three times a day, to confirm that participants will accept the study diets and adhere to the study procedures. On study days 2 and 4, in comparison group A, participants will receive either the Diet-ZBfR or Diet-CR based on the random assignments, and participants will receive Diet-CR or Diet ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4), Likewise, in comparison group B, the participants will receive either Diet-ZBfR or Diet-CR+Z on days 2 and 4 based on the random assignments, and participants will receive Diet-CR+Z or the Diet-ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4). Investigators will use zinc stable isotope tracer techniques 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
Last Updated

June 15, 2022

Status Verified

May 1, 2011

Enrollment Period

1.3 years

First QC Date

April 27, 2011

Last Update Submit

June 12, 2022

Conditions

Malnourished Children

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)

    10 days

Study Arms (2)

Group A

OTHER

zinc biofortified rice-based diet (Diet-ZBfR) will be compared with conventional rice-based diet (Diet- CR)

Other: Diet-ZnBfROther: Diet- CR

Group B

OTHER

zinc biofortified rice-based diet (Diet-ZBfR) will be compared with a rice-based diet plus zinc fortificant (Diet-CR+Z)

Other: Diet-ZnBfROther: CR + Zn

Interventions

Diet-ZnBfROTHER

zinc biofortified rice-based diet

Group A
Diet- CROTHER

conventional rice-based diet

Group A
CR + ZnOTHER

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

Group B

Eligibility Criteria

Age36 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: 42 children aged 36-59 mo; Either sex
  • WLZ and HAZ: \>-2 Z-Score
  • No longer breastfed
  • No H/O diarrhoea in last 14 days
  • Given anti-helminthics in last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

  • Islam MM, Woodhouse LR, Hossain MB, Ahmed T, Huda MN, Ahmed T, Peerson JM, Hotz C, Brown KH. Total zinc absorption from a diet containing either conventional rice or higher-zinc rice does not differ among Bangladeshi preschool children. J Nutr. 2013 Apr;143(4):519-25. doi: 10.3945/jn.112.169169. Epub 2013 Feb 20.

    PMID: 23427330DERIVED

MeSH Terms

Interventions

zinc(II) chromium(III) hydroxide 2,2'-azino-di-(3-ethylbenzothiazoline)-6-sulfonate

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2011

First Posted

May 3, 2011

Study Start

October 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 15, 2022

Record last verified: 2011-05

Locations

BA(1)