Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 3:36 PM
Study NCT ID:
NCT01125033
Status:
COMPLETED
Last Update Posted:
2011-06-17
First Post:
2010-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-07-15', 'releaseDate': '2011-06-20'}, {'resetDate': '2011-08-16', 'releaseDate': '2011-07-19'}], 'estimatedResultsFirstSubmitDate': '2011-06-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-16', 'studyFirstSubmitDate': '2010-05-14', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change in IRLS Sum Score', 'timeFrame': '8 Weeks', 'description': 'Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '8 Weeks', 'description': 'Number of participants with adverse events throughout the treatment phase of the study would be assessed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E'], 'conditions': ['Restless Legs Syndrome', 'Kidney Failure, Chronic']}, 'referencesModule': {'references': [{'pmid': '37916745', 'type': 'DERIVED', 'citation': 'Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.', 'detailedDescription': 'RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who fulfill Restless leg syndrome international criteria(IRLSSG)\n* Patients who are stable on HD without any internment illness or admission\n\nExclusion Criteria:\n\n* Patients who have renal stone\n* Patients who receive medications with RLS aggravating or alleviating properties'}, 'identificationModule': {'nctId': 'NCT01125033', 'acronym': 'ShirazUMS', 'briefTitle': 'Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '86-3893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C & Vitamin E.', 'description': 'The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks', 'interventionNames': ['Drug: Vitamin C & Vitamin E']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin C & Placebo', 'description': 'The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.', 'interventionNames': ['Drug: Vitamin C']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin E & Placebo', 'description': 'The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.', 'interventionNames': ['Drug: Vitamin E']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double Placebo', 'description': 'The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.', 'interventionNames': ['Drug: Vitamin C Placebo & Vitamin E Placebo']}], 'interventions': [{'name': 'Vitamin C & Vitamin E', 'type': 'DRUG', 'description': 'The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks', 'armGroupLabels': ['Vitamin C & Vitamin E.']}, {'name': 'Vitamin C', 'type': 'DRUG', 'description': 'The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.', 'armGroupLabels': ['Vitamin C & Placebo']}, {'name': 'Vitamin E', 'type': 'DRUG', 'description': 'The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.', 'armGroupLabels': ['Vitamin E & Placebo']}, {'name': 'Vitamin C Placebo & Vitamin E Placebo', 'type': 'DRUG', 'description': 'The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.', 'armGroupLabels': ['Double Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Hamideh Akbari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences'}, {'name': 'Mohammad Mahdi Sagheb, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shiraz University of Medical Sciences'}, {'name': 'Sahar Sohrabi Nazari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences'}, {'name': 'Mohammad Kazem Fallahzadeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Vice Chancellor for Research At Shiraz University of Medical Sciences', 'oldOrganization': 'Shiraz Nephro-Urology Research Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-06-20', 'type': 'RELEASE'}, {'date': '2011-07-15', 'type': 'RESET'}, {'date': '2011-07-19', 'type': 'RELEASE'}, {'date': '2011-08-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shiraz Nephro-Urology Research Center (Vice Chancellor for Research At Shiraz University of Medical Sciences)'}}}}