Effect of B-vitamin therapy on progression of diabetic nephropathy: a randomized controlled trial
- PMID: 20424250
- DOI: 10.1001/jama.2010.490
Effect of B-vitamin therapy on progression of diabetic nephropathy: a randomized controlled trial
Abstract
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.
Comment in
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B-vitamin therapy for diabetic nephropathy.JAMA. 2010 Aug 11;304(6):636; author reply 636-7. doi: 10.1001/jama.2010.1105. JAMA. 2010. PMID: 20699451 No abstract available.
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B-vitamin therapy for diabetic nephropathy.JAMA. 2010 Aug 11;304(6):636; author reply 636-7. doi: 10.1001/jama.2010.1104. JAMA. 2010. PMID: 20699452 No abstract available.
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In diabetic nephropathy, high doses of vitamin B decrease glomerular filtration rate and increase risk of the composite outcome of a vascular event or all-cause mortality compared with placebo.Evid Based Med. 2011 Feb;16(1):14-5. doi: 10.1136/ebm1141. Epub 2010 Nov 3. Evid Based Med. 2011. PMID: 21047842 No abstract available.
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