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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002612
First Posted: October 27, 2009
Last Update Posted: November 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mahidol University
South Eastern Area Health Service
Information provided by:
Thai Red Cross AIDS Research Centre
  Purpose
To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.

Condition
HIV Infection HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • Growth parameters (weight and height), blood lipid levels and dietary intakes [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children [ Time Frame: 6 months ]

Enrollment: 73
Study Start Date: December 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thai HIV-infected children living in a family style community located in rural central region of Thailand
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002612


Locations
Thailand
The Thai Red Cross AIDS Research Centre
Pathumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
Mahidol University
South Eastern Area Health Service
Investigators
Principal Investigator: Praphan Phanuphak, MD The Thai Red Cross AIDS Research Centre
  More Information

Responsible Party: Supabhorn Pengnonyang, Nurse Nutritionist, Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT01002612     History of Changes
Other Study ID Numbers: TACHIN003.1
First Submitted: October 23, 2009
First Posted: October 27, 2009
Last Update Posted: November 9, 2009
Last Verified: October 2009

Keywords provided by Thai Red Cross AIDS Research Centre:
Nutritional status
Thai HIV-infected children

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases