Food Security and Nutrition in Rural Cambodia
This study is currently recruiting participants.
Verified February 2013 by University of British Columbia
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01593423
First received: April 20, 2012
Last updated: February 18, 2013
Last verified: February 2013
| Tracking Information | |||||
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| First Received Date ICMJE | April 20, 2012 | ||||
| Last Updated Date | February 18, 2013 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in nutritionally related biochemical measures at 22 months [ Time Frame: At baseline and 22 months ] [ Designated as safety issue: No ] Haemoglobin (g/l) Haematocrit (%) Serum Ferritin (ng/ml) White Cell Count (x109/l) Red Cell Count (x1012/l) Mean Corpuscular Volume (fl) Mean Cell Haemoglobin (pg) Red Cell Width % Platelet Count (x109/l) Neutrophils % Eosinophils % Lymphocytes % Monocytes % Neutrophils # (x109/l) Eosinophils # (x109/l) Lymphocytes # (x109/l) Monocytes # (x109/l) C-Reactive Protein (mg/l) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01593423 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Food Security and Nutrition in Rural Cambodia | ||||
| Official Title ICMJE | Integration of Small-scale Aquaculture With Homestead Food Production for Improved Household Food Security and Nutrition in Rural Cambodia | ||||
| Brief Summary | The project is a three arm randomized control trial in rural Cambodia designed to evaluate the impact of homestead food production (home gardens) with and without fish ponds versus control on household food security, dietary intake of women and youngest child, biochemical nutritional status of women, and household livelihoods over a 22 month period. Baseline and end line surveys will be conducted that involve questionnaires and a blood sample. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Household Food Security | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 900 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
In addition village model farm owners will:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Cambodia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01593423 | ||||
| Other Study ID Numbers ICMJE | H12-00451 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of British Columbia | ||||
| Study Sponsor ICMJE | University of British Columbia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||
| Verification Date | February 2013 | ||||
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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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