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Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community (TACHIN003-1)

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ClinicalTrials.gov Identifier: NCT01002612
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : November 9, 2009
Sponsor:
Collaborators:
Mahidol University
South Eastern Area Health Service
Information provided by:
Thai Red Cross AIDS Research Centre

Tracking Information
First Submitted Date October 23, 2009
First Posted Date October 27, 2009
Last Update Posted Date November 9, 2009
Study Start Date December 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2009)
Growth parameters (weight and height), blood lipid levels and dietary intakes [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 24, 2009)
Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community
Official Title 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Condition
  • HIV Infection
  • HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 24, 2009)
73
Original Actual Enrollment Same as current
Actual Study Completion Date August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children age 4-15 years old
  • Confirmed HIV-1 diagnosis
  • Reside at the community
  • The guardian must be able and willing to provide written informed consent. Oral consent in the presence of witness is acceptable in the case of illiteracy

Exclusion Criteria:

  • non-HIV infected children
  • Age 0-3 years
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT01002612
Other Study ID Numbers TACHIN003.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Supabhorn Pengnonyang, Nurse Nutritionist, Thai Red Cross AIDS Research Centre
Study Sponsor Thai Red Cross AIDS Research Centre
Collaborators
  • Mahidol University
  • South Eastern Area Health Service
Investigators
Principal Investigator: Praphan Phanuphak, MD The Thai Red Cross AIDS Research Centre
PRS Account Thai Red Cross AIDS Research Centre
Verification Date October 2009