Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT00798993
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2008-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'C104450', 'term': '25-hydroxyvitamin D'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-06', 'studyFirstSubmitDate': '2008-11-26', 'studyFirstSubmitQcDate': '2008-11-26', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise capacity - modified shuttle walk test', 'timeFrame': 'Basesline, 3 & 6 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life with KDQOL', 'timeFrame': 'Baseline, 3 & 6 months'}, {'measure': 'Quadriceps Strength', 'timeFrame': 'Baseline, 3 & 6 months'}, {'measure': 'Serum phosphate', 'timeFrame': 'baselibe, 3 & 6 months'}, {'measure': 'Feeling thermometer', 'timeFrame': 'Baseline, 3 & 6 months'}, {'measure': 'Timed up and go', 'timeFrame': 'baseline, 3 & 6 months'}, {'measure': 'Falls', 'timeFrame': 'continuous'}, {'measure': 'Pulse wave velocity', 'timeFrame': 'baseline, 3 & 6 months'}, {'measure': 'Bioimpedance', 'timeFrame': 'Baseline, 3 & 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic kidney failure', '25 hydroxyvitamin D', 'falls', 'exercise', 'quadriceps strength'], 'conditions': ['End Stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stable on dialysis for at least 3 months\n2. Able to obtain informed consent\n3. Medically stable\n4. Dialysis adequacy at target for small solute clearance (ie Kt/V\\>1.2 or Urea reduction ratio\\>65%)\n5. Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline\n\nExclusion Criteria:\n\n1. Limb Amputation\n2. Impaired cognition\n3. Impaired vision\n4. Haemoglobin concentration \\< 110g/L\n5. Change in Erythropoiesis stimulating agent dose over the last 2 months\n6. Unable or unwilling to comply with exercise program'}, 'identificationModule': {'nctId': 'NCT00798993', 'briefTitle': 'Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sir Charles Gairdner Hospital'}, 'officialTitle': 'The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients', 'orgStudyIdInfo': {'id': 'SCGH25OHD2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Structured exercise program', 'description': 'Participants will be randomised at 3 months into either this group or the comparator of usual exercise.', 'interventionNames': ['Other: Structured Exercise program']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'Cholecalciferol 2000U per day will be given to all participants for the duration of the study', 'interventionNames': ['Drug: Cholecalciferol (25-Hydroxyvitamin D)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual exercise', 'description': 'Participants randomised to this arm, at 3 months, will continue on their usual exercise routine', 'interventionNames': ['Other: Usual exercise']}], 'interventions': [{'name': 'Structured Exercise program', 'type': 'OTHER', 'description': '30 minutes on an exercise bicycle during every dialysis', 'armGroupLabels': ['Structured exercise program']}, {'name': 'Cholecalciferol (25-Hydroxyvitamin D)', 'type': 'DRUG', 'description': 'Cholecalciferol 2000U per day will be given for duration of study to all participants', 'armGroupLabels': ['Vitamin D']}, {'name': 'Usual exercise', 'type': 'OTHER', 'description': 'Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months', 'armGroupLabels': ['Usual exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Ben Bull', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Charles Gairdner Hospital'}, {'name': 'Neil Boudville', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sir Charles Gairdner Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Charles Gairdner Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Neil Boudville', 'investigatorAffiliation': 'Sir Charles Gairdner Hospital'}}}}