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ISRCTN
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ISRCTN41332305
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DOI
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10.1186/ISRCTN41332305
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Do vitamins for homocyst(e)ine slow progression of diabetic nephropathy?
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Scientific title
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Lowering total homocysteine using vitamins to slow the progression of diabetic nephropathy: a randomised controlled trial
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Acronym
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DIVINe
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Serial number at source
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MCT-41551
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Study hypothesis
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To test whether lowering total homocysteine with vitamins slows progression of diabetic nephropathy.
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Lay summary
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Ethics approval
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University of Western Ontario, Office of Research Ethics approved on the 31st May 2005
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Diabetic nephropathy
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Participants - inclusion criteria
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1. Type I or type II diabetes mellitus
2. Clinical or histological diagnosis of diabetic nephropathy
3. Urinary albumin excretion level of at least 300 mg/day or urinary protein level of at least 500 mg/day (based upon a 24 hour urine collection) within the past 24 months
4. Patient is able and willing to give informed consent
5. Over the age of 18 years old, either sex
6. Individual patient co-operation is obtained for regular follow-up until completion of the trial
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Participants - exclusion criteria
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1. Patient starting on an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker who has been taking the drug for less than three months. (After a three-month time period the patient may then be considered eligible for the trial).
2. Patient not expected to survive three years because of intercurrent cancer or other severe illness
3. Patient expected to be non-compliant; who will not adhere to the study visit protocol, who will not take the study vitamins or who will not discontinue previous multivitamin or B-complex vitamin use
4. Patient on dialysis or imminently expected to require dialysis
5. Other known renal disease that may impact on progression rate (i.e. renal artery stenosis or glomerular renal disease such as membranous nephropathy)
6. Women of childbearing potential who are unwilling to practice a form of birth control for the duration on the trial deemed appropriate by the Investigator
7. Patient with a creatinine clearance of less than 30 ml/min based on the Cockcroft-Gault method or less than 25 ml/min if the patient is currently on an ACE inhibitor or angiotensin receptor blocker (within 30 days prior to randomization if less than 35 ml/min or within 6 months if greater than or equal to 35 ml/min)
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Anticipated start date
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01/10/2000
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Anticipated end date
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30/09/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300
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Interventions
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Placebo versus active vitamin combination tablet once daily.
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Primary outcome measure(s)
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The change in glomerular filtration rate (GFR)
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Secondary outcome measure(s)
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1. Renal outcomes (change from baseline in urea, creatinine, urinary albumin excretion, creatinine clearance, and progression to dialysis or transplantation)
2. Vascular events (stroke, death, myocardial infarction, revascularisation)
3. Cognitive decline
4. Progression of carotid intima-media thickness and plaque volume (London study centre only)
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41551)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20424250
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Contact name
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Dr
John David
Spence
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Address
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Stroke Prev. & Ath. Research Centre
Robarts Research Institute
Siebens-Drake Research Bldg.
1400 Western Rd.
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City/town
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London, Ontario
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Zip/Postcode
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N6G 2V2
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Country
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Canada
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Tel
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+1 519 663 3113
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Fax
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+1 519 663 3018
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Email
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dspence@robarts.ca
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Sponsor
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John P. Robarts Research Institute (Canada)
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Address
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P.O. Box 5015
100 Perth Drive
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City/town
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London, Ontario
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Zip/Postcode
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N6A 5K8
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Country
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Canada
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Tel
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+1 519 663 5777
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Fax
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+1 519 663 3789
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Email
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info@robarts.ca
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Date applied
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01/09/2005
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Last edited
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29/04/2010
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Date ISRCTN assigned
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01/09/2005
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