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ORIGINAL RESEARCH COMMUNICATION |
1 From the Division of Cardiovascular and Medical Sciences (DJS, GDOL, AR, PL, and PWM), the Nursing & Midwifery School (GM), and the Robertson Centre for Biostatistics (ADM), University of Glasgow, Glasgow, United Kingdom; the Departments of Haematology (RCT) and Pathological Biochemistry (DSJO), Glasgow Royal Infirmary, Glasgow, United Kingdom; the Department of Geriatric Medicine, Garnavel General Hospital, Glasgow, United Kingdom (EGS and JBM); and the Section of Gerontology and Geriatrics, Leiden University Medical Centre, Leiden, Netherlands (RGJW)
Background: Homocysteine is an independent risk factor for vascular disease and is associated with dementia in older people. Potential mechanisms include altered endothelial and hemostatic function.
Objective: We aimed to determine the effects of folic acid plus vitamin B-12, riboflavin, and vitamin B-6 on homocysteine and cognitive function.
Design: This was a factorial 2 x 2 x 2, randomized, placebo-controlled, double-blind study with 3 active treatments: folic acid (2.5 mg) plus vitamin B-12 (500 µg), vitamin B-6 (25 mg), and riboflavin (25 mg). We studied 185 patients aged 
65 y with ischemic vascular disease. Outcome measures included plasma homocysteine, fibrinogen, and von Willebrand factor at 3 mo and cognitive change (determined with the use of the Letter Digit Coding Test and on the basis of the Telephone Interview of Cognitive Status) after 1 y.
Results: The mean (±SD) baseline plasma homocysteine concentration was 16.5 ± 6.4 µmol/L. This value was 5.0 (95% CI: 3.8, 6.2) µmol/L lower in patients given folic acid plus vitamin B-12 than in patients not given folic acid plus vitamin B-12 but did not change significantly with vitamin B-6 or riboflavin treatment. Homocysteine lowering with folic acid plus vitamin B-12 had no significant effect, relative to the 2 other treatments, on fibrinogen, von Willebrand factor, or cognitive performance as measured by the Letter Digit Coding Test (mean change: –1; 95% CI: –2.3, 1.4) and the Telephone Interview of Cognitive Status (–0.7; 95% CI: –1.7, 0.4).
Conclusion: Oral folic acid plus vitamin B-12 decreased homocysteine concentrations in elderly patients with vascular disease but was not associated with statistically significant beneficial effects on cognitive function over the short or medium term.
Key Words: Elderly • homocysteine • folic acid • vitamin B-12 • riboflavin • vitamin B-6 • randomized controlled trial • cognitive function
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