Diabetic nephropathy Urological and Genital Diseases Nephropathy
Conditions
Interventions
Placebo versus active vitamin combination tablet once daily.
Sponsors
John P. Robarts Research Institute (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in glomerular filtration rate (GFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Canada
Outcome results
None listed