HIV InfectionTACHIN003-1NCT01002612
Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community
An observational study of HIV Infection and HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- HIV Infection, HIV Infections
- How many people
- 73 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2007to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Thai HIV-infected children living in a family style community located in rural central region of Thailand
Who may be able to join
- 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
Who cannot join
- non-HIV infected children
- Age 0-3 years
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Pathumwan, Bangkok, 10330
About this study
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
To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.
Read the 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.
- Conditions
- HIV Infection, HIV Infections
- Keywords
- Nutritional status, Thai HIV-infected children
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth parameters (weight and height), blood lipid levels and dietary intakes
Measured: 6 months
Secondary outcomes (1)
Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startDec 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, South Eastern Area Health Service
- Investigators
- Praphan Phanuphak, MD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002612
- Sponsor's protocol ID
- TACHIN003.1
- Acronym
- TACHIN003-1
- Status last verified
- Oct 2009
- First submitted
- 23 Oct 2009
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01002612
- Acronym / sponsor ID
- TACHIN003-1 / TACHIN003.1
- Conditions
- HIV Infection, HIV Infections
- Keywords
- Nutritional status, Thai HIV-infected children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Mahidol University, South Eastern Area Health Service
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Thai HIV-infected children living in a family style community located in rural central region of Thailand
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- non-HIV infected children
- Age 0-3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Growth parameters (weight and height), blood lipid levels and dietary intakes
Time frame: 6 months
1 secondary outcome
Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praphan Phanuphak, MD principal investigator
Thai Red Cross AIDS Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth parameters (weight and height), blood lipid levels and dietary intakes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2009.