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Do vitamins for homocyst(e)ine slow progression of diabetic nephropathy?
ISRCTN ISRCTN41332305
DOI 10.1186/ISRCTN41332305
ClinicalTrials.gov identifier
EudraCT number
Public title Do vitamins for homocyst(e)ine slow progression of diabetic nephropathy?
Scientific title Lowering total homocysteine using vitamins to slow the progression of diabetic nephropathy: a randomised controlled trial
Acronym DIVINe
Serial number at source MCT-41551
Study hypothesis To test whether lowering total homocysteine with vitamins slows progression of diabetic nephropathy.
Lay summary
Ethics approval University of Western Ontario, Office of Research Ethics approved on the 31st May 2005
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Diabetic nephropathy
Participants - inclusion criteria 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
Participants - exclusion criteria 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)
Anticipated start date 01/10/2000
Anticipated end date 30/09/2005
Status of trial Completed
Patient information material
Target number of participants 300
Interventions Placebo versus active vitamin combination tablet once daily.
Primary outcome measure(s) The change in glomerular filtration rate (GFR)
Secondary outcome measure(s) 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)
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41551)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20424250
Contact name Dr  John David  Spence
  Address Stroke Prev. & Ath. Research Centre
Robarts Research Institute
Siebens-Drake Research Bldg.
1400 Western Rd.
  City/town London, Ontario
  Zip/Postcode N6G 2V2
  Country Canada
  Tel +1 519 663 3113
  Fax +1 519 663 3018
  Email dspence@robarts.ca
Sponsor John P. Robarts Research Institute (Canada)
  Address P.O. Box 5015
100 Perth Drive
  City/town London, Ontario
  Zip/Postcode N6A 5K8
  Country Canada
  Tel +1 519 663 5777
  Fax +1 519 663 3789
  Email info@robarts.ca
Date applied 01/09/2005
Last edited 29/04/2010
Date ISRCTN assigned 01/09/2005
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