Vitamins B12, B6, and Folic Acid for Onset of Depressive Symptoms in Older Men: Results From a 2-Year Placebo-Controlled Randomized Trial
J Clin Psychiatry 2008;69(8):1203-1209
© Copyright 2014 Physicians Postgraduate Press, Inc.
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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
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
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.
Trial Registration: www.anzctr.org.au Identifier: ACTRN012605000045617