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B vitamins and the risk of total mortality and cardiovascular disease in end-stage renal disease: results of a randomized controlled trial.
Circulation 2010; 121(12):1432-8Circ

Abstract

BACKGROUND

In observational studies, hyperhomocysteinemia has been found to be a risk factor for total mortality and cardiovascular events in patients with end-stage renal disease. These patients have grossly elevated homocysteine levels that can be lowered by supplementation with folic acid and vitamin B(12). We conducted a randomized clinical trial with B vitamins to reduce homocysteine levels and therefore cardiovascular events and total mortality.

METHODS AND RESULTS

This randomized, double-blind multicenter study was conducted in 33 dialysis centers in north and east Germany between July 2002 and July 2008. We randomly assigned 650 patients with end-stage renal disease who were undergoing hemodialysis to 2 postdialysis treatments: 5 mg folic acid, 50 microg vitamin B(12), and 20 mg vitamin B(6) (active treatment) or 0.2 mg folic acid, 4 microg vitamin B(12), and 1.0 mg vitamin B(6) (placebo) given 3 times per week for an average of 2 years. The primary outcome was total mortality; the secondary outcome was fatal and nonfatal cardiovascular events. The primary outcome occurred in 102 patients (31%) receiving the active treatment and in 92 (28%) receiving placebo (hazard ratio, 1.13; 95% confidence interval, 0.85 to 1.50; P=0.51). The secondary outcome occurred in 83 patients (25%) receiving the active treatment and in 98 (30%) receiving placebo (hazard ratio, 0.80; 95% confidence interval, 0.60 to 1.07; P=0.13).

CONCLUSIONS

Increased intake of folic acid, vitamin B(12), and vitamin B(6) did not reduce total mortality and had no significant effect on the risk of cardiovascular events in patients with end-stage renal disease. Clinical Trial Registration- URL: www.anzctr.org.au. Unique identifier: ACTRN12609000911291. URL: www.cochrane-renal.org. Unique identifier: CRG010600027.

Authors+Show Affiliations

Institute of Clinical Chemistry, Magdeburg University Hospital, Magdeburg, Germany. j.heinz@uke.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20231532

Citation

Heinz, Judith, et al. "B Vitamins and the Risk of Total Mortality and Cardiovascular Disease in End-stage Renal Disease: Results of a Randomized Controlled Trial." Circulation, vol. 121, no. 12, 2010, pp. 1432-8.
Heinz J, Kropf S, Domröse U, et al. B vitamins and the risk of total mortality and cardiovascular disease in end-stage renal disease: results of a randomized controlled trial. Circulation. 2010;121(12):1432-8.
Heinz, J., Kropf, S., Domröse, U., Westphal, S., Borucki, K., Luley, C., ... Dierkes, J. (2010). B vitamins and the risk of total mortality and cardiovascular disease in end-stage renal disease: results of a randomized controlled trial. Circulation, 121(12), pp. 1432-8. doi:10.1161/CIRCULATIONAHA.109.904672.
Heinz J, et al. B Vitamins and the Risk of Total Mortality and Cardiovascular Disease in End-stage Renal Disease: Results of a Randomized Controlled Trial. Circulation. 2010 Mar 30;121(12):1432-8. PubMed PMID: 20231532.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - B vitamins and the risk of total mortality and cardiovascular disease in end-stage renal disease: results of a randomized controlled trial. AU - Heinz,Judith, AU - Kropf,Siegfried, AU - Domröse,Ute, AU - Westphal,Sabine, AU - Borucki,Katrin, AU - Luley,Claus, AU - Neumann,Klaus H, AU - Dierkes,Jutta, Y1 - 2010/03/15/ PY - 2010/3/17/entrez PY - 2010/3/17/pubmed PY - 2010/5/25/medline SP - 1432 EP - 8 JF - Circulation JO - Circulation VL - 121 IS - 12 N2 - BACKGROUND: In observational studies, hyperhomocysteinemia has been found to be a risk factor for total mortality and cardiovascular events in patients with end-stage renal disease. These patients have grossly elevated homocysteine levels that can be lowered by supplementation with folic acid and vitamin B(12). We conducted a randomized clinical trial with B vitamins to reduce homocysteine levels and therefore cardiovascular events and total mortality. METHODS AND RESULTS: This randomized, double-blind multicenter study was conducted in 33 dialysis centers in north and east Germany between July 2002 and July 2008. We randomly assigned 650 patients with end-stage renal disease who were undergoing hemodialysis to 2 postdialysis treatments: 5 mg folic acid, 50 microg vitamin B(12), and 20 mg vitamin B(6) (active treatment) or 0.2 mg folic acid, 4 microg vitamin B(12), and 1.0 mg vitamin B(6) (placebo) given 3 times per week for an average of 2 years. The primary outcome was total mortality; the secondary outcome was fatal and nonfatal cardiovascular events. The primary outcome occurred in 102 patients (31%) receiving the active treatment and in 92 (28%) receiving placebo (hazard ratio, 1.13; 95% confidence interval, 0.85 to 1.50; P=0.51). The secondary outcome occurred in 83 patients (25%) receiving the active treatment and in 98 (30%) receiving placebo (hazard ratio, 0.80; 95% confidence interval, 0.60 to 1.07; P=0.13). CONCLUSIONS: Increased intake of folic acid, vitamin B(12), and vitamin B(6) did not reduce total mortality and had no significant effect on the risk of cardiovascular events in patients with end-stage renal disease. Clinical Trial Registration- URL: www.anzctr.org.au. Unique identifier: ACTRN12609000911291. URL: www.cochrane-renal.org. Unique identifier: CRG010600027. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/20231532/B_vitamins_and_the_risk_of_total_mortality_and_cardiovascular_disease_in_end_stage_renal_disease:_results_of_a_randomized_controlled_trial_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.109.904672?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -