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Zinc Absorption From Zinc Biofortified Rice

This study has been completed.
Sponsor:
Collaborators:
HarvestPlus
International Atomic Energy Agency
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01346722
First received: April 27, 2011
Last updated: May 2, 2011
Last verified: May 2011

April 27, 2011
May 2, 2011
October 2009
January 2011   (final data collection date for primary outcome measure)
Total absorbed zinc [ Time Frame: 10 days ] [ Designated as safety issue: No ]

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)

Same as current
Complete list of historical versions of study NCT01346722 on ClinicalTrials.gov Archive Site
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Zinc Absorption From Zinc Biofortified Rice
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.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Malnourished Children
  • Other: Diet-ZnBfR
    zinc biofortified rice-based diet
  • Other: Diet- CR
    conventional rice-based diet
  • Other: CR + Zn
    conventional rice-based diet plus zinc fortificant (Diet-CR+Z).
  • Group A
    zinc biofortified rice-based diet (Diet-ZBfR) will be compared with conventional rice-based diet (Diet- CR)
    Interventions:
    • Other: Diet-ZnBfR
    • Other: Diet- CR
  • Group B
    zinc biofortified rice-based diet (Diet-ZBfR) will be compared with a rice-based diet plus zinc fortificant (Diet-CR+Z)
    Interventions:
    • Other: Diet-ZnBfR
    • Other: CR + Zn
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2011
January 2011   (final data collection date for primary outcome measure)

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

-

Both
36 Months to 59 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT01346722
2008046
No
Dr Md. Munirul Islam, International Centre for Diarrhoeal Disease Research, Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
  • HarvestPlus
  • International Atomic Energy Agency
Not Provided
International Centre for Diarrhoeal Disease Research, Bangladesh
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP