Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-02 @ 9:20 AM
Study NCT ID:
NCT05066503
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2021-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-24', 'size': 368183, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-15T16:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4.', 'timeFrame': 'As determined over an up to 4-day intervention duration.', 'description': 'CAM-S and 4 AT is a tool to determine and quantify delirium. Subjects in the non-control arms will undergo this test twice each day. The score ranges from 0-7, with lower numbers being better (little to no signs of delirium).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subacute Delirium']}, 'descriptionModule': {'briefSummary': 'The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 60 people will be enrolled.20 will be asked to drink this blend twice a day for up to 4 days, and 20 will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products.', 'detailedDescription': 'This will be an interventional pilot study to determine the effectiveness of a specific amino acid supplement developed by the investigators versus standard treatment in mitigating delirium in geriatric patients hospitalized at UAMS for certain infections. Up to 40 delirious and 20 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (60 subjects maximum). Twenty patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 20 patients with delirium will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products. All subjects will undergo 2-5 blood draws and 3-7 cognitive assessments while they are admitted to the hospital, depending on study group assignment and discharge date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Delirious cohort\n\n1. Aged 60 years and older.\n2. Documented presence of either delirium, acute confusion, or altered mental status in medical record.\n3. Currently hospitalized with a diagnosis of one of the following:\n\n 1. sepsis/septicemia\n 2. Pneumonia\n 3. Urinary tract infection\n 4. Clostridium-difficile infection\n 5. Other bone or tissue infection\n 6. Fever of unknown origin\n\nInclusion Criteria: NON-Delirious cohort\n\n1. Aged 60 years and older.\n2. Current diagnosis of one of the following:\n\n 1. sepsis/septicemia\n 2. Pneumonia\n 3. Urinary tract infection\n 4. Clostridium-difficile infection\n 5. Other bone or tissue infection\n 6. Fever of unknown origin\n\nExclusion Criteria: all subjects\n\n1. Chronic kidney disease (eGFR \\<30).\n2. Admitted to the hospital for major psychiatric illness.\n3. Major psychiatric illness not controlled by medication/treatment.\n4. Delirium etiology of drug overdose or alcohol withdrawal.\n5. Major surgery within the past five days.\n6. Known or suspected Covid-19 positive.\n7. Continuous feeding tube'}, 'identificationModule': {'nctId': 'NCT05066503', 'briefTitle': 'Nutritional Therapy for Delirium in Elderly Hospitalized Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Nutritional Therapy for Delirium in Elderly Hospitalized Subjects', 'orgStudyIdInfo': {'id': '260279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Delirious subjects receiving active study product', 'description': 'Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.', 'interventionNames': ['Dietary Supplement: 260279 active study product']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Delirious control group and non-delirious control group who receives standard treatment in the hospital.'}], 'interventions': [{'name': '260279 active study product', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['there is not a non-proprietary name for this supplement.'], 'description': 'The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.', 'armGroupLabels': ['Delirious subjects receiving active study product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Reino Henderson, PA', 'role': 'CONTACT', 'email': 'RAHenderson@uams.edu', 'phone': '501-603-1514'}, {'name': 'Jeanne Wei, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Regina Gibson, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karen Coker, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pankaj Patyal, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Wolfe, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gohar Azhar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shakshi Sharma, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizabeth Eoff, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maneetha Kodali, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Obioma Nwaiwu, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chander Agarwal, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Archy Cui, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Navya Nalajala, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Malodee Harris, D.N.P', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UAMS Center on Aging', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'centralContacts': [{'name': 'Gohar Azhar, M.D.', 'role': 'CONTACT', 'email': 'azhargohar@uams.edu', 'phone': '5015265935'}], 'overallOfficials': [{'name': 'Gohar Azhar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}