Background. Hyper-homocyst(e)inemia is an independent risk factor for atherosclerotic vascular disease in patients with end-stage renal disease (ESRD), although optimal treatment remains unknown. This randomized, double-blind, placebo-controlled study was designed to measure the effect of high-dose oral vitamin B12 and folic acid on predialysis total homocyst(e)ine levels in patients with ESRD. Methods. We studied 81 hemodialysis patients who had hyper-homocyst(e)inemia (>16 μmol/L) on varied doses of a multivitamin containing 1 mg of folic acid/day. After screening blood work, all patients were switched to daily multivitamin therapy, including 1 mg of folic acid for four weeks. For all patients, vitamin B12, 1 mg/day, was added for an additional four weeks. Patients were then randomized to receive four weeks of 0, 5, or 20 mg of folic acid in addition to the multivitamin and vitamin B12 (all given daily). Results. Screening homocyst(e)ine levels (mean 27.7 μmol/L) decreased by 19.2% after four weeks of treatment with a daily multivitamin containing 1 mg of folic acid (P < 0.001). Homocyst(e)ine levels were reduced further from 22.3 to 18.6 μmol/L (mean reduction 16.7%, 95% CI 11.8 to 21.6%, P < 0.001) after four weeks of therapy with vitamin B12 (1 mg/day). There was no significant difference in mean reduction of homocyst(e)ine levels after therapy with high-dose folic acid compared with placebo (P = 0.35). Conclusions. The optimal oral treatment of hyper-homocyst(e)inemia in hemodialysis patients consists of 1 mg of folic acid and 1 mg of oral vitamin B12 daily. Whether this treatment will lower the risk of future atherosclerotic vascular events remains to be investigated.
CITATION STYLE
Manns, B., Hyndman, E., Burgess, E., Parsons, H., Schaefer, J., Snyder, F., & Scott-Douglas, N. (2001). Oral vitamin B12 and high-dose folic acid in hemodialysis patients with hyper-homocyst(e)inemia. Kidney International, 59(3), 1103–1109. https://doi.org/10.1046/j.1523-1755.2001.0590031103.x
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