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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01002612
Other study ID # TACHIN003.1
Secondary ID
Status Completed
Phase N/A
First received October 23, 2009
Last updated November 6, 2009
Start date December 2007
Est. completion date August 2008

Study information

Verified date October 2009
Source Thai Red Cross AIDS Research Centre
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 15 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand The Thai Red Cross AIDS Research Centre Pathumwan Bangkok

Sponsors (3)

Lead Sponsor Collaborator
Thai Red Cross AIDS Research Centre Mahidol University, South Eastern Area Health Service

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth parameters (weight and height), blood lipid levels and dietary intakes 6 months No
Secondary Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children 6 months No
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