Zinc Absorption From Zinc Biofortified Rice
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 27, 2011 |
| Last Updated Date | May 2, 2011 |
| Start Date ICMJE | October 2009 |
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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) |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01346722 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Zinc Absorption From Zinc Biofortified Rice |
| Official Title ICMJE | 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. |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 1 Phase 2 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Condition ICMJE | Malnourished Children |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 42 |
| Completion Date | January 2011 |
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | 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 - |
| Gender | Both |
| Ages | 36 Months to 59 Months |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Bangladesh |
| Administrative Information | |
| NCT Number ICMJE | NCT01346722 |
| Other Study ID Numbers ICMJE | 2008046 |
| Has Data Monitoring Committee | No |
| Responsible Party | Dr Md. Munirul Islam, International Centre for Diarrhoeal Disease Research, Bangladesh |
| Study Sponsor ICMJE | International Centre for Diarrhoeal Disease Research, Bangladesh |
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided |
| Information Provided By | International Centre for Diarrhoeal Disease Research, Bangladesh |
| Verification Date | May 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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