Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-05 @ 2:12 AM
Study NCT ID:
NCT03352895
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2017-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Resveratrol on the Complications of Patients With Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}, {'id': 'D056604', 'term': 'Grape Seed Extract'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-22', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pure tone audiometry (PTA)', 'timeFrame': 'one year', 'description': 'pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.'}], 'secondaryOutcomes': [{'measure': 'Speech Audiometry', 'timeFrame': 'one year', 'description': 'Speech reception thresholds and speech discrimination scores were tested.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resveratrol', 'chronic kidney disease'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': "Participants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All participants will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score.", 'detailedDescription': "Patients with chronic kidney disease (CKD) often suffered from hearing impairment, vertigo/dizziness, cognitive degeneration, cardiovascular diseases. In addition, compared to patients without CKD, the longevity of patients with CKD was also shorter. The mechanism underlying the complications of CKD were very complicated, but were generally associated with uremic toxins, tissue hypoxia, free radicals damages. Meanwhile, some co-morbidities, for example, diabetes mellitus, hypertension, atherosclerosis, would also worsen the complications of CKD. However, only limited methods were reported to have beneficial effects on renal function and its complications. For, example, controlling co-morbidities of CKD, avoiding nephrotoxic substances, and dialysis.\n\nResveratrol, it could prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of resveratrol on hearing impairment, tinnitus, vertigo/dizziness, cognitive degeneration, cancer development, death in patients with CKD were also unclear.\n\nThis study aimed to investigate the beneficial effects of resveratrol on hearing impairment in patients with CKD by a prospective, randomized, double-blinded clinical trial design.\n\nParticipants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All patients will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic kidney disease (CKD) and routine hemodialysis\n* Age limits 40\\~69 years old\n* Normal hearing or symmetrical sensorineural hearing loss, all ears frequency differences are less than 15 dB\n\nExclusion Criteria:\n\n* Life can not take care of themselves or the bed of a patient\n* Acceptance of peritoneal dialysis patients\n* Moderate hearing loss (pure tone average hearing threshold greater than 50 dB)\n* Moderate or severe cognitive impairment (Mini-Mental State Examination score less than 21 points)\n* The details of the study can not understand or can not fit the patient examination.\n* A history of alcohol or drug abuse\n* The high ambient noise exposure history\n* Poor guide backbone pure tone hearing thresholds greater than 10 decibels, trying to listen to 4 kilohertz air conduction threshold is greater than 8 kilohertz air conduction threshold value of 20 dB\n* Before the age of 30 have hearing loss\n* Had a stroke, myocardial infarction, a history of cancer\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT03352895', 'briefTitle': 'The Effects of Resveratrol on the Complications of Patients With Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Dalin Tzu Chi General Hospital'}, 'officialTitle': 'The Effects of Resveratrol on the Complications of Patients With Hemodialysis: a Prospective, Randomized, Double-blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'B10401008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Control group will receive placebo medication therapy', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'test group', 'description': 'resveratrol group will receive oral resveratrol (100 mg per day)', 'interventionNames': ['Dietary Supplement: resveratrol']}], 'interventions': [{'name': 'resveratrol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Grape seed extract'], 'description': 'Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg', 'armGroupLabels': ['test group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Maltodextrin'], 'description': 'The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66247', 'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Dalin Tzu Chi Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}], 'overallOfficials': [{'name': 'Juen-Haur Hwang, MD, PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Dalin Tzu Chi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalin Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}