Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-22 @ 11:18 AM
Study NCT ID:
NCT00755768
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2008-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-18', 'studyFirstSubmitDate': '2008-09-17', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'phosphate control'}, {'measure': 'calcium phosphate product'}], 'secondaryOutcomes': [{'measure': 'parathyroid hormone'}, {'measure': 'number and type of phosphate binders prescribed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'phosphate', 'calcium phosphate product', 'dietician', 'dietetic advice'], 'conditions': ['Renal Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether spending more time with a dietitian will improve dietary compliance in a group of hemodialysis patients, with particular respect to phosphate control.', 'detailedDescription': '* randomised prospective controlled trial\n* stable haemodialysis patients on thrice weekly haemodialysis (URR \\> 66%)\n* either had standard dietetic review - 6 monthly or intensive review - monthly\n* all patients had to have a serum phosphate \\> 1.8 mmol/l over the previous three months to be recruited\n* study period 6 months, and then patients followed for a further 3 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable chronic hemodialysis patients\n* serum phosphate \\> 1.8 mmol/l sustained over 3 months prior to trial entry adequate dialysis treatment as assessed by urea reduction\n\nExclusion Criteria:\n\n* pregnancy\n* unable to give consent\n* phosphate \\< 1.8 mmol/l\n* inadequate dialysis\n* aged \\< 18 or \\> 80\n* poor nutritional state\n* weight loss in proceeding three months'}, 'identificationModule': {'nctId': 'NCT00755768', 'briefTitle': 'More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients', 'nctIdAliases': ['NCT00454727'], 'organization': {'class': 'OTHER', 'fullName': 'Royal Free Hampstead NHS Trust'}, 'officialTitle': 'More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients', 'orgStudyIdInfo': {'id': '05/Q0504/46'}, 'secondaryIdInfos': [{'id': 'BRS grant'}, {'id': 'R&D 7119M'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'additional review by dietician', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW3 2QG', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'UCL Center for Nephrology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'andrew davenport, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL Center for nephrology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Free Hampstead NHS Trust', 'class': 'OTHER'}}}}