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Vitamins B12, B6, and Folic Acid for Onset of Depressive Symptoms in Older Men: Results From a 2-Year Placebo-Controlled Randomized Trial
Objective: To examine whether use of vitamins B12, B6, and folate was associated with reduced severity of depressive symptoms and 2-year incidence of clinically significant depression.
Method: The investigators recruited 299 men aged 75 years and older free of clinically significant depression (Beck Depression Inventory [BDI] score < 18). They were randomly assigned to treatment with 400 micrograms B12 + 2 mg folic acid + 25 mg B6 per day (N = 150) or placebo (N = 149). The BDI was the primary outcome measure of the study. Follow-up assessments took place 6, 12, 18, and 24 months after baseline. Analyses were intention-to-treat. The study was conducted from June 2001 to June 2004.
Results: 118 and 123 men treated with vitamins and placebo, respectively, completed this 2-year trial (19.4% dropout rate). Analysis of variance for repeated measures showed that there was no difference between the groups (F = 0.76, df = 1, p = .384) nor was there a significant change of BDI scores over time (F = 1.26, df = 4, p = .284). Cox regression revealed that participants treated with vitamins were 24% more likely to remain free of depression during the trial, although the difference between groups was not significant (95% CI = 0.68 to 2.28). At the end of the study, 84.3% of men treated with vitamins and 79.1% of those treated with placebo remained free of clinically significant depressive symptoms. The number of people needed to treat to show benefit was 21.
Conclusion: The results of this study showed that treatment with B12, folic acid, and B6 is no better than placebo at reducing the severity of depressive symptoms or the incidence of clinically significant depression over a period of 2 years in older men.