Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-03 @ 3:01 PM
Study NCT ID:
NCT02475928
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2015-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc Supplementation in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004408', 'term': 'Dysgeusia'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D013651', 'term': 'Taste Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030691', 'term': 'gluconic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysgeusia', 'timeFrame': 'Presence of any taste disorder at 6 months', 'description': 'Evaluation of presence of any taste disorder, according to questionnaires and evaluation of perception and recognition thresholds with ascending molar concentrations of basic tastes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dysgeusia', 'Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of zinc supplementation in the treatment for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.', 'detailedDescription': 'Taste disorders are symptomatologies in patients with cirrhosis, these have a direct effect in modification of food consumption, increasing weight loss, anorexia and malnutrition, which impacts in decompensation rates and mortality.\n\nIt has been proposed that zinc deficiency is one of the causes for development of taste disorders. The aim of this study is to describe the presence of taste disorders in patients with cirrhosis and evaluate the effect of zinc supplementation in treatment of taste disorders, and in progression of chronic liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhotic patients by any etiology, with any dysgeusia\n\nExclusion Criteria:\n\n* Patients with hepatic encephalopathy at the time of dysgeusia evaluation\n* Patients with any neurological disease\n* Patients with respiratory diseases ath the time of dysgeusia evaluation\n* Patients with active alcohol consumption'}, 'identificationModule': {'nctId': 'NCT02475928', 'acronym': 'ZnDCP', 'briefTitle': 'Zinc Supplementation in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Clínica Médica Sur'}, 'officialTitle': 'Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'Cirrhosis01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '100 mg placebo', 'description': '100 mg Placebo plus nutritional education', 'interventionNames': ['Dietary Supplement: Placebo', 'Behavioral: Nutritional education']}, {'type': 'EXPERIMENTAL', 'label': '100 mg zinc supplement', 'description': 'Nutritional education plus 100 mg of zinc gluconate', 'interventionNames': ['Dietary Supplement: zinc gluconate', 'Behavioral: Nutritional education']}], 'interventions': [{'name': 'zinc gluconate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc supplementation plus nutritional education', 'armGroupLabels': ['100 mg zinc supplement']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['100 mg placebo']}, {'name': 'Nutritional education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['100 mg placebo', '100 mg zinc supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Varenka J Barbero-Becerra, PhD', 'role': 'CONTACT', 'email': 'vbarberob@medicasur.org.mx', 'phone': '54247200'}], 'facility': 'Medica Sur Clinic & Foundation', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Norberto C Chávez-Tapia, PhD', 'role': 'CONTACT', 'email': 'nchavezt@medicasur.org.mx', 'phone': '54246850'}, {'name': 'Eva Juárez-Hernández', 'role': 'CONTACT', 'email': 'evajuarezh@hotmail.com', 'phone': '54246850'}], 'overallOfficials': [{'name': 'Norberto C Chávez-Tapia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medica Sur Clinic & Foundation'}, {'name': 'Eva Juárez-Hernández', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medica Sur Clinic & Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Clínica Médica Sur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Obesity and Digestive Diseases Unit Chief', 'investigatorFullName': 'Norberto Carlos Chavez Taia', 'investigatorAffiliation': 'Fundación Clínica Médica Sur'}}}}