Author Contributions: Dr Eliasziw had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: House, Eliasziw, Cattran, Churchill, Dresser, Spence.
Acquisition of data: House, Cattran, Churchill, Oliver, Fine, Spence.
Analysis and interpretation of data: House, Eliasziw, Cattran, Oliver, Dresser, Spence.
Drafting of the manuscript: House, Eliasziw, Spence.
Critical revision of the manuscript for important intellectual content: House, Eliasziw, Cattran, Churchill, Oliver, Fine, Dresser, Spence.
Statistical analysis: House, Eliasziw, Oliver.
Obtained funding: House, Cattran, Spence.
Administrative, technical, or material support: Cattran, Churchill, Fine, Dresser, Spence.
Study supervision: House, Cattran, Churchill, Oliver, Spence.
Financial Disclosures: Dr Spence reported receiving in the past consulting fees from Pan American Laboratories in the United States and from Medice Arzneimittel Pütter GmbH & Co in Germany. Drs House and Spence have a patent pending on the use of mesna, a thiol, to reduce homocysteine levels in patients receiving dialysis. No other authors reported any financial disclosures.
Funding/Support: This work was funded by grant MCT-41551 from the Canadian Institutes of Health Research and by the Kidney Foundation of Canada. Pan American Laboratories (Covington, Louisiana) provided in-kind the B vitamins and matching placebos.
Role of the Sponsors: The sponsors had no role in the design and conduct of the study, in the collection, management, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript.
Diabetic Intervention with Vitamins to Improve Nephropathy (DIVINe) Trial Organization: J. David Spence, MD (principal investigator); Misha Eliasziw, PhD (biostatistician); Leslie Paddock, RN, Lorraine Fleming, RN (trial coordinators); George Dresser, MD (chair of data and safety monitoring committee); and Robarts Clinical Trials, London, Ontario, Canada (data management).
Canadian Participating Centers: University Hospital, London, Ontario (105 participants): Andrew House, MD, J. David Spence, MD (investigators); Michelle Von Lewinsky, RN, Ruth Bullas, RN (coordinators); Toronto General Hospital, Toronto, Ontario (63 participants): Daniel Cattran, MD (investigator); Naomi Ryan, RN, Paul Ling, RN (coordinators); St. Joseph's Hospital, Hamilton, Ontario (44 participants): David Churchill, MD (investigator); Nancy Winegard, RN (coordinator); Sunnybrook Hospital, Toronto, Ontario (26 participants): Matthew Oliver, MD (investigator); Laura Lodberg, RN (coordinator); St. Boniface General Hospital, Winnipeg, Manitoba (14 participants): Adrian Fine, MD (investigator); Bunny Fontaine, RN (coordinator).
Previous Presentation: An abstract of this work was presented at the American Society of Nephrology 42nd Annual Meeting and Scientific Exposition; October 27-November 1, 2009; San Diego, California.
Additional Contributions: We thank all the study participants. Brian Feagan, MD (Robarts Research Institute), provided very helpful suggestions to the manuscript. He did not receive any compensation for his contribution.