Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01002612
Status:
COMPLETED
Last Update Posted:
2009-11-09
First Post:
2009-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-06', 'studyFirstSubmitDate': '2009-10-23', 'studyFirstSubmitQcDate': '2009-10-24', 'lastUpdatePostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth parameters (weight and height), blood lipid levels and dietary intakes', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutritional status', 'Thai HIV-infected children'], 'conditions': ['HIV Infection', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thai HIV-infected children living in a family style community located in rural central region of Thailand', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children age 4-15 years old\n* Confirmed HIV-1 diagnosis\n* Reside at the community\n* 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\n\nExclusion Criteria:\n\n* non-HIV infected children\n* Age 0-3 years'}, 'identificationModule': {'nctId': 'NCT01002612', 'acronym': 'TACHIN003-1', 'briefTitle': 'Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community', 'organization': {'class': 'OTHER', 'fullName': 'Thai Red Cross AIDS Research Centre'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TACHIN003.1'}}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathumwan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'The Thai Red Cross AIDS Research Centre'}], 'overallOfficials': [{'name': 'Praphan Phanuphak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Thai Red Cross AIDS Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thai Red Cross AIDS Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mahidol University', 'class': 'OTHER'}, {'name': 'South Eastern Area Health Service', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Supabhorn Pengnonyang, Nurse Nutritionist', 'oldOrganization': 'Thai Red Cross AIDS Research Centre'}}}}