Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 3:31 PM
Study NCT ID:
NCT01171495
Status:
COMPLETED
Last Update Posted:
2010-07-28
First Post:
2010-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Nutrition Intervention on HIV/AIDS Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047053', 'term': 'Theragran-M'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-27', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of nutritional intervention on anthropometry in HIV infected individuals.', 'timeFrame': '6 months', 'description': 'Body Mass Index'}], 'secondaryOutcomes': [{'measure': 'Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.', 'timeFrame': '6 months', 'description': 'Immune status (CD4 cell count, total lymphocyte count), antioxidant status.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'Nutrition Therapy', 'Dietary Supplement', 'Antioxidant', 'Immunity', 'CD4 count', 'Anthropometry', 'Body Mass Index'], 'conditions': ['Human Immunodeficiency Virus (HIV)', 'Acquired Immune Deficiency Syndrome (AIDS)']}, 'descriptionModule': {'briefSummary': 'Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.', 'detailedDescription': "To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.\n\nA total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).\n\nParticipants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV positive individuals in the age range 18 to 50 years.\n* Individuals whose CD4 count was between 300-550 cells/uL.\n* Individuals who met the study criteria and were interested in being enrolled.\n* Individuals not on ARV therapy.\n* Women who were not pregnant.\n\nExclusion Criteria:\n\n* On the clinician's advice, individuals could be excluded from enrollment.\n* Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.\n* Individuals who were unlikely to complete follow-up based on pre-enrolment assessment."}, 'identificationModule': {'nctId': 'NCT01171495', 'acronym': 'INI', 'briefTitle': 'Impact of Nutrition Intervention on HIV/AIDS Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Caribbean Health Research Council'}, 'officialTitle': 'Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica', 'orgStudyIdInfo': {'id': 'CHRC 51016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ensure Plus + Multivitamin/Counselling', 'interventionNames': ['Dietary Supplement: Theragran-M; Ensure Plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multivitamin/Counselling', 'interventionNames': ['Dietary Supplement: Theragran-M']}], 'interventions': [{'name': 'Theragran-M; Ensure Plus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Theragran-M: One tablet daily for 6-months. Ensure Plus: One 8 fl.oz. bottle daily for 6-months. Nutritional counselling: at baseline, and at monthly follow-up visits.', 'armGroupLabels': ['Ensure Plus + Multivitamin/Counselling']}, {'name': 'Theragran-M', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.', 'armGroupLabels': ['Multivitamin/Counselling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kingston', 'country': 'Jamaica', 'facility': 'Comprehensive Health Centre', 'geoPoint': {'lat': 17.99702, 'lon': -76.79358}}], 'overallOfficials': [{'name': 'Sharon M Dawson, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the West Indies, Mona ,Jamaica, West Indies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caribbean Health Research Council', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of The West Indies', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Sharon Dawson', 'oldOrganization': 'Ministry of Health,Kingston, Jamaica and The University of the West Indies, Mona, Jamaica'}}}}