A pilot study of thiamine and folic acid in hemodialysis patients with cognitive impairment

Abstract

Background: This study aimed to explore the effectiveness of thiamine and folic acid supplementation on the improvement of the cognitive function in patients with maintenance hemodialysis. Methods: In the present study, we randomly assigned patients undergoing hemodialysis who had the Montreal Cognitive Assessment (MoCA) score lower than 26 to treatment group (n=25, thiamine 90mg/day combined with folic acid 30mg/day) or control group (n=25, nonintervention). All subjects were followed up for 96 weeks. The primary outcome was the improvement of the MoCA score. The secondary outcomes included homocysteine level, survival and safety. Results: Patients in treatment group had an increase of the MoCA score from 21.95±3.81 at baseline to 25.68±1.96 at week 96 (P<0.001, primary outcome), as compared with the MoCA score from 20.69±3.40 to 19.62±3.58 in control group. Thiamine combined with folic acid treatment also resulted in lower level of serum homocysteine in treatment group compare with control group at week 96 (P<0.05, secondary outcome). 3 patients and 9 patients died during follow-up period in treatment and control group respectively (P=0.048). The proportion of adverse events in treatment group was significantly lower than that in control group. Conclusion: Hemodialysis patients with cognitive impairment treated with thiamine and folic acid had a significant improvement in MoCA score. Trial registration: Clinical trial registration number: ChiCTR-IPR-17012210.