Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT04073693
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2019-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000596', 'term': 'Amino Acids'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of muscle mass in patients with sarcopenia', 'timeFrame': '12 weeks', 'description': 'To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '34074812', 'type': 'DERIVED', 'citation': 'Hernandez-Conde M, Llop E, Gomez-Pimpollo L, Fernandez Carrillo C, Rodriguez L, Van Den Brule E, Perello C, Lopez-Gomez M, Abad J, Martinez-Porras JL, Fernandez-Puga N, Ferre C, Trapero M, Fraga E, Calleja JL. Adding Branched-Chain Amino Acids to an Enhanced Standard-of-Care Treatment Improves Muscle Mass of Cirrhotic Patients With Sarcopenia: A Placebo-Controlled Trial. Am J Gastroenterol. 2021 Nov 1;116(11):2241-2249. doi: 10.14309/ajg.0000000000001301.'}]}, 'descriptionModule': {'briefSummary': 'In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhotic patients with sarcopenia in abdominal CT.\n\nExclusion Criteria:\n\n* chronic renal failure or being on hemodialysis\n* active hepatitis B or C virus infection\n* active alcohol abuse\n* coinfection with human immunodeficiency virus\n* renal or previous liver transplantation\n* history of neoplasia requiring chemotherapy or radiotherapy\n* hepatocellular carcinoma outside of Milan criteria\n* TIPs\n* unwillingness to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04073693', 'briefTitle': 'Characterization of the Nutritional Status in the Patient With Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia', 'orgStudyIdInfo': {'id': '11.17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BRCA', 'description': 'They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise.', 'interventionNames': ['Dietary Supplement: Branched chain amino acids (BRCA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'They only were on standard treatment based on nutritional intervention and physical exercise.', 'interventionNames': ['Dietary Supplement: Branched chain amino acids (BRCA)']}], 'interventions': [{'name': 'Branched chain amino acids (BRCA)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'They were with BRCA during the day apart of following the standard recommendations', 'armGroupLabels': ['BRCA', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Jose Luis Calleja', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director. Clinical Research', 'investigatorFullName': 'Jose Luis Calleja', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}