Homocysteine (Hcy) increase is now widely accepted as a risk factor for vas
cular disease. The effects of folic acid (FA) and vitamins B-12 and B-6 in
lowering Hey have been extensively studied, but there is still little data
on the response to FA dietary administration. Our purpose was to evaluate t
he impact of the diet and the degree of response to different doses of phar
macological FA supplementation. In a prospective, randomized, and simple bl
ind study, 50 elderly subjects were given a 400-mug/day FA diet and were ra
ndomly assigned to one of the following treatments: Group I = placebo table
t; Group II = tablet containing 1-mg folic acid, 1-mg B-12, and 25-mg B-6;
and Group III = tablet containing 2.5-mg folic acid and same B-6 and B-12 d
oses as Group II. Forty-four subjects completed the study, and their plasma
s were evaluated. Hcy concentration significantly decreased even in patient
s with normal basal values, and there were no differences in the response b
etween individuals receiving diet plus placebo and those receiving diet plu
s pharmacological supplementation. After the treatment, the mean decrease o
f plasmatic Hey levels was 10.8 (9.4, 12.5) mu mol/l, geometric mean [95% c
onfidence interval (95% CI)], and particularly, the values for Group I were
10.6 (7.4, 14.8) mu mol/l. In 31% of the subjects, the post-treatment Hey
levels were less than or equal to5 mu mol/l. These results show that a spec
ial diet, with or without pharmacological FA and B-12 and B-6 supplementati
on, significantly decreases the Hey levels in elderly people. Therefore, a
diet with high contents of FA might have an enormous impact on the morbidit
y and mortality of atherothrombosis. (C) 2000 Elsevier Science Ltd. All rig
hts reserved.