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The article offers information on a study which investigated the effects of treatment with B vitamins on cancer outcomes and all-cause mortality. A total of 6837 patients were recruited to participate in two randomized, double-blind, placebo-controlled clinical trials conducted in Norway between 1998 and 2005, and followed up through December 31, 2007. Treatment interventions included oral treatment with folic acid combined with vitamin B12 and vitamin 6, folic acid combined with vitamin B12, vitamin 6 alone and placebo. Presented in details are the research findings.

Context: Recently, concern has been raised about the safety of folic acid, particularly in relation to cancer risk.Objective: To evaluate effects of treatment with B vitamins on cancer outcomes and all-cause mortality in 2 randomized controlled trials.Design, Setting, and Participants: Combined analysis and extended follow-up of participants from 2 randomized, double-blind, placebo-controlled clinical trials (Norwegian Vitamin Trial and Western Norway B Vitamin Intervention Trial). A total of 6837 patients with ischemic heart disease were treated with B vitamins or placebo between 1998 and 2005, and were followed up through December 31, 2007.Interventions: Oral treatment with folic acid (0.8 mg/d) plus vitamin B(12) (0.4 mg/d) and vitamin B(6) (40 mg/d) (n = 1708); folic acid (0.8 mg/d) plus vitamin B(12) (0.4 mg/d) (n = 1703); vitamin B(6) alone (40 mg/d) (n = 1705); or placebo (n = 1721).Main Outcome Measures: Cancer incidence, cancer mortality, and all-cause mortality.Results: During study treatment, median serum folate concentration increased more than 6-fold among participants given folic acid. After a median 39 months of treatment and an additional 38 months of posttrial observational follow-up, 341 participants (10.0%) who received folic acid plus vitamin B(12) vs 288 participants (8.4%) who did not receive such treatment were diagnosed with cancer (hazard ratio [HR], 1.21; 95% confidence interval [CI], 1.03-1.41; P = .02). A total of 136 (4.0%) who received folic acid plus vitamin B(12) vs 100 (2.9%) who did not receive such treatment died from cancer (HR, 1.38; 95% CI, 1.07-1.79; P = .01). A total of 548 patients (16.1%) who received folic acid plus vitamin B(12) vs 473 (13.8%) who did not receive such treatment died from any cause (HR, 1.18; 95% CI, 1.04-1.33; P = .01). Results were mainly driven by increased lung cancer incidence in participants who received folic acid plus vitamin B(12). Vitamin B(6) treatment was not associated with any significant effects.Conclusion: Treatment with folic acid plus vitamin B(12) was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway, where there is no folic acid fortification of foods.Trial Registration: clinicaltrials.gov Identifier: NCT00671346. [ABSTRACT FROM AUTHOR]

The article offers information on a study which investigated the effects of treatment with B vitamins on cancer outcomes and all-cause mortality. A total of 6837 patients were recruited to participate in two randomized, double-blind, placebo-controlled clinical trials conducted in Norway between 1998 and 2005, and followed up through December 31, 2007. Treatment interventions included oral treatment with folic acid combined with vitamin B12 and vitamin 6, folic acid combined with vitamin B12, vitamin 6 alone and placebo. Presented in details are the research findings.