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Zinc Absorption From Zinc Biofortified Rice

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ClinicalTrials.gov Identifier: NCT01346722
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : May 3, 2011
Sponsor:
Collaborators:
Information provided by:

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. Implementation of large scale programmes are needed for prevention of zinc deficiency in areas where it is common. 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 and even if implemented might not be sustainable in the long range. There thus 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.

To assess the potentials for biofortified rice in providing a good, bioavailable source of additional zinc, the investigators propose to measure zinc absorption from rice-based meals among Bangladeshi preschool children. Specifically, the investigators will measure the amount of zinc absorbed from zinc-biofortified rice (Diet-ZBfR, 24 mg Zn/kg), compared to that absorbed from a conventional Bangladeshi rice (Diet-CR, 16 mg Zn/kg) (control). The investigators will also compare the zinc absorption from biofortified rice with that from zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized, controlled clinical study. In total, 42 children aged 36-59 months of either sex will be recruited from a peri-urban community in Dhaka, and they will be individually randomized, in equal numbers, to one of the two comparison groups, A and B. The group A children will receive zinc biofortified rice-based diet (Diet-ZBfR) and conventional rice-based diet (Diet-CR) using a randomized, cross-over design. Similarly, the group B children will receive zinc biofortified rice-based diet (Diet-ZBfR) and a zinc fortified rice based diet (Diet-CR+Z), also using randomized, cross-over design. The 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 two-day period. If zinc from biofortified rice is found to be adequately bioavailable, it will be tested in a randomized, controlled, efficacy trial among rural Bangladeshi children.


Condition or disease Intervention/treatment Phase
Malnourished Children Other: Diet-ZnBfR Other: Diet- CR Other: CR + Zn Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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 in a Peri-urban Community.
Study Start Date : October 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011
Arms and Interventions

Arm Intervention/treatment
Group A
zinc biofortified rice-based diet (Diet-ZBfR) will be compared with conventional rice-based diet (Diet- CR)
Other: Diet-ZnBfR
zinc biofortified rice-based diet
Other: Diet- CR
conventional rice-based diet
Group B
zinc biofortified rice-based diet (Diet-ZBfR) will be compared with a rice-based diet plus zinc fortificant (Diet-CR+Z)
Other: Diet-ZnBfR
zinc biofortified rice-based diet
Other: CR + Zn
conventional rice-based diet plus zinc fortificant (Diet-CR+Z).


Outcome Measures

Primary Outcome Measures :
  1. Total absorbed zinc [ Time Frame: 10 days ]

    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)



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

NOt meeting the inclusion criteria

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346722


Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
HarvestPlus
International Atomic Energy Agency
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Md. Munirul Islam, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01346722     History of Changes
Other Study ID Numbers: 2008046
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs