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Completed

NCT Number: NCT01002612

Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community

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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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Pathumwan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Growth parameters (weight and height), blood lipid levels and dietary intakes

    Time frame: 6 months

Secondary outcomes

  1. Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

  • Mahidol University
  • South Eastern Area Health Service

Registry information

Official study 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

Acronym: TACHIN003-1

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 27, 2009
Registry last updated
Nov 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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