| Effect of B-vitamin therapy on progression of diabetic nephropathy: a randomized controlled trial. | |
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MedLine Citation:
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PMID: 20424250 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: Hyperhomocysteinemia is frequently observed in patients with diabetic nephropathy. B-vitamin therapy (folic acid, vitamin B(6), and vitamin B(12)) has been shown to lower the plasma concentration of homocysteine. OBJECTIVE: To determine whether B-vitamin therapy can slow progression of diabetic nephropathy and prevent vascular complications. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, randomized, double-blind, placebo-controlled trial (Diabetic Intervention with Vitamins to Improve Nephropathy [DIVINe]) at 5 university medical centers in Canada conducted between May 2001 and July 2007 of 238 participants who had type 1 or 2 diabetes and a clinical diagnosis of diabetic nephropathy. INTERVENTION: Single tablet of B vitamins containing folic acid (2.5 mg/d), vitamin B(6) (25 mg/d), and vitamin B(12) (1 mg/d), or matching placebo. MAIN OUTCOME MEASURES: Change in radionuclide glomerular filtration rate (GFR) between baseline and 36 months. Secondary outcomes were dialysis and a composite of myocardial infarction, stroke, revascularization, and all-cause mortality. Plasma total homocysteine was also measured. RESULTS: The mean (SD) follow-up during the trial was 31.9 (14.4) months. At 36 months, radionuclide GFR decreased by a mean (SE) of 16.5 (1.7) mL/min/1.73 m(2) in the B-vitamin group compared with 10.7 (1.7) mL/min/1.73 m(2) in the placebo group (mean difference, -5.8; 95% confidence interval [CI], -10.6 to -1.1; P = .02). There was no difference in requirement of dialysis (hazard ratio [HR], 1.1; 95% CI, 0.4-2.6; P = .88). The composite outcome occurred more often in the B-vitamin group (HR, 2.0; 95% CI, 1.0-4.0; P = .04). Plasma total homocysteine decreased by a mean (SE) of 2.2 (0.4) micromol/L at 36 months in the B-vitamin group compared with a mean (SE) increase of 2.6 (0.4) micromol/L in the placebo group (mean difference, -4.8; 95% CI, -6.1 to -3.7; P < .001, in favor of B vitamins). CONCLUSION: Among patients with diabetic nephropathy, high doses of B vitamins compared with placebo resulted in a greater decrease in GFR and an increase in vascular events. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN41332305. |
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Authors:
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Andrew A House; Misha Eliasziw; Daniel C Cattran; David N Churchill; Matthew J Oliver; Adrian Fine; George K Dresser; J David Spence |
Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 303 ISSN: 1538-3598 ISO Abbreviation: JAMA Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-04-28 Completed Date: 2010-04-28 Revised Date: 2011-02-11 |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: United States |
Other Details:
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Languages: eng Pagination: 1603-9 Citation Subset: AIM; IM |
Affiliation:
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Division of Nephrology, University of Western Ontario, London, Ontario, Canada. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ISRCTN/ISRCTN41332305 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Diabetic Nephropathies / complications*, drug therapy Double-Blind Method Female Folic Acid / administration & dosage*, adverse effects Glomerular Filtration Rate Humans Hyperhomocysteinemia / drug therapy*, etiology Kidney / drug effects, physiopathology Male Middle Aged Vitamin B 12 / administration & dosage*, adverse effects Vitamin B 6 / administration & dosage*, adverse effects Vitamin B Complex / administration & dosage*, adverse effects |
| Grant Support | |
ID/Acronym/Agency:
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MCT-41551//Canadian Institutes of Health Research |
| Chemical | |
Reg. No./Substance:
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12001-76-2/Vitamin B Complex; 59-30-3/Folic Acid; 68-19-9/Vitamin B 12; 8059-24-3/Vitamin B 6 |
| Comments/Corrections | |
Comment In:
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Evid Based Med. 2011 Feb;16(1):14-5
[PMID:
21047842
]
Praxis (Bern 1994). 2010 Aug 11;99(16):987-8 [PMID: 20700876 ] JAMA. 2010 Aug 11;304(6):636; author reply 636-7 [PMID: 20699451 ] JAMA. 2010 Aug 11;304(6):636; author reply 636-7 [PMID: 20699452 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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