Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community (TACHIN003-1)
| Tracking Information | |||||
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| First Received Date ICMJE | October 23, 2009 | ||||
| Last Updated Date | November 6, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Growth parameters (weight and height), blood lipid levels and dietary intakes [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01002612 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| 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 | Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community | ||||
| Official Title ICMJE | Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community: 6 Months After Nutrition Care Support by the Thai-Australian Collaboration HIV-Nutrition (TACHIN) Project | ||||
| Brief Summary | To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months. |
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| Detailed Description | The first assessment indicated that improving dietary intake, either energy or micronutrient intakes, to meet the recommended for HIV-infected children (CLHIV) would be able to improve growth of these children. We implemented the nutrition support program through the two strategies aiming to increase dietary intake for all children to meet the current World Health Organization (WHO) recommendations which the recommended energy requirements are increased by10% for asymptomatic CLHIV and increased by 20 to 50% for children who require catch up growth or experiencing opportunistic infections. The nutrition support program composed two strategies. Firstly is providing nutrition education to caregivers and also children. Secondly, revision food menus by caregivers with assisting from the nutritionists of the project. After this program have been implemented for 6 months, reassessment is needed to evaluate the changes of nutritional status and health outcomes in this children aiming to further providing support and applying to other settings. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Thai HIV-infected children living in a family style community located in rural central region of Thailand |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 73 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Years to 15 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01002612 | ||||
| Other Study ID Numbers ICMJE | TACHIN003.1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Supabhorn Pengnonyang, Nurse Nutritionist, Thai Red Cross AIDS Research Centre | ||||
| Study Sponsor ICMJE | Thai Red Cross AIDS Research Centre | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Thai Red Cross AIDS Research Centre | ||||
| Verification Date | October 2009 | ||||
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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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