Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT01278693
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2011-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-18', 'studyFirstSubmitDate': '2011-01-18', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lipid profile', 'timeFrame': 'at sixteen weeks after admission'}], 'secondaryOutcomes': [{'measure': 'anemia', 'timeFrame': 'at sixteen weeks after admission'}, {'measure': 'quality of life', 'timeFrame': 'at sixteen weeks after admission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal failure, hemodialysis, dyslipidemia, L-carnitine.'], 'conditions': ['Complication of Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '36472884', 'type': 'DERIVED', 'citation': 'Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.', 'detailedDescription': 'In patients under maintenance hemodialysis several factors reduce the body stored carnitine which in turn affected dyslipidemia, anemia, and general health in these patients. The investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nbeing in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration \\>200 mg/dl or serum HDL concentration \\>40 mg/dl in the beginning of the study.\n\nExclusion Criteria:\n\ntaking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.'}, 'identificationModule': {'nctId': 'NCT01278693', 'briefTitle': 'Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Study of Treatment of Dyslipidemia for Hemodialysis', 'orgStudyIdInfo': {'id': 'ASD-1213-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'placebo', 'description': 'it is as like as L-carnitine in shape', 'interventionNames': ['Drug: placebo']}, {'type': 'OTHER', 'label': 'L-carnitine', 'description': 'it is kind of supplement', 'interventionNames': ['Drug: L-carnitine']}], 'interventions': [{'name': 'L-carnitine', 'type': 'DRUG', 'description': '500 mg,twice daily, 16 weeks', 'armGroupLabels': ['L-carnitine']}, {'name': 'placebo', 'type': 'DRUG', 'description': '500 mg,twice daily, 16 weeks.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Noor university hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'Mahnaz Moradi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'MD,research comittee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Alireza Yousefy, Associate Professor of Medical Education', 'oldOrganization': 'Isfahan University of Medical Sciences'}}}}