Do vitamins for homocyst(e)ine slow progression of diabetic nephropathy?
| ISRCTN | ISRCTN41332305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41332305 |
| Protocol serial number | MCT-41551 |
| Sponsor | John P. Robarts Research Institute (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41551) |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 29/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John David Spence
Scientific
Scientific
Stroke Prev. & Ath. Research Centre
Robarts Research Institute
Siebens-Drake Research Bldg.
1400 Western Rd.
London, Ontario
N6G 2V2
Canada
| Phone | +1 519 663 3113 |
|---|---|
| dspence@robarts.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Lowering total homocysteine using vitamins to slow the progression of diabetic nephropathy: a randomised controlled trial |
| Study acronym | DIVINe |
| Study objectives | To test whether lowering total homocysteine with vitamins slows progression of diabetic nephropathy. |
| Ethics approval(s) | University of Western Ontario, Office of Research Ethics approved on the 31st May 2005 |
| Health condition(s) or problem(s) studied | Diabetic nephropathy |
| Intervention | Placebo versus active vitamin combination tablet once daily. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
The change in glomerular filtration rate (GFR) |
| Key secondary outcome measure(s) |
1. Renal outcomes (change from baseline in urea, creatinine, urinary albumin excretion, creatinine clearance, and progression to dialysis or transplantation) |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Stroke Prev. & Ath. Research Centre
London, Ontario
N6G 2V2
Canada
N6G 2V2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/04/2010 | Yes | No |
