Efficacy Of Methylcobalamin To Normalise Elevated Homocysteine Of Vitamin B12 Deficient Vegetarians: A Double Blind Placebo Control Study

Vegetarians are known to be deficient in vitamin B12, due to a lack of dietary animal products, which can elevate plasma total homocysteine (tHcy). Elevated total tHcy can render vegetarians susceptible to cardiovascular disease (CVD). There are a limited number of published studies in relation to the efficacy of methylcobalamin to normalise plasma tHcy of vitamin B12 deficient vegetarians. The primary objective of the present study was to explore the relationship between supplementary oral methylcobalamin and levels of tHcy of vitamin B12 deficient vegetarians; to reduce the risk of developing primary CVD. A randomised double blind placebo controlled pilot study was conducted to monitor and analyse baseline and post treatment levels of plasma tHcy, 49 volunteer vegetarians were recruited to participate in this study. Statistical analysis employing SPSS software indicated that methylcobalamin reduced mean baseline plasma tHcy of 15.5 mu molL(-1) (n=39) to a mean plasma tHcy level of 8.4 mu molL(-1) (P < 0.001). In a second group that contained details of ten withdrawn participants, which was conducted on an 'Intention to Treat' (ITT) basis, indicated that methylcobalamin was shown to be reduced from a mean baseline plasma tHcy of 14.7 mu molL(-1)(n=49) to a mean plasma tHcy level of 9.1 mu molL(-1) (P < 0.001). The findings of the study have the potential to alert vegetarians of the possible risk of becoming vitamin B12 deficient, and to help avoid the risk of developing homocysteine related CVD. The quality data obtained in the study will allow an accurate sample size to be calculated for a future definite clinical study.