Condition category
Urological and Genital Diseases
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
29/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John David Spence

ORCID ID

Contact details

Stroke Prev. & Ath. Research Centre
Robarts Research Institute
Siebens-Drake Research Bldg.
1400 Western Rd.
London
Ontario
N6G 2V2
Canada
+1 519 663 3113
dspence@robarts.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-41551

Study information

Scientific title

Lowering total homocysteine using vitamins to slow the progression of diabetic nephropathy: a randomised controlled trial

Acronym

DIVINe

Study hypothesis

To test whether lowering total homocysteine with vitamins slows progression of diabetic nephropathy.

Ethics approval

University of Western Ontario, Office of Research Ethics approved on the 31st May 2005

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diabetic nephropathy

Intervention

Placebo versus active vitamin combination tablet once daily.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamins

Primary outcome measures

The change in glomerular filtration rate (GFR)

Secondary outcome measures

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)

Overall trial start date

01/10/2000

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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)

Recruitment start date

01/10/2000

Recruitment end date

30/09/2005

Locations

Countries of recruitment

Canada

Trial participating centre

Stroke Prev. & Ath. Research Centre
London, Ontario
N6G 2V2
Canada

Sponsor information

Organisation

John P. Robarts Research Institute (Canada)

Sponsor details

P.O. Box 5015
100 Perth Drive
London
Ontario
N6A 5K8
Canada
+1 519 663 5777
info@robarts.ca

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41551)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20424250

Publication citations

  1. Results

    House AA, Eliasziw M, Cattran DC, Churchill DN, Oliver MJ, Fine A, Dresser GK, Spence JD, Effect of B-vitamin therapy on progression of diabetic nephropathy: a randomized controlled trial., JAMA, 2010, 303, 16, 1603-1609, doi: 10.1001/jama.2010.490.

Additional files

Editorial Notes