A randomised controlled trial of B-vitamin supplementation on neuropsychiatric performance: results from the BrainHOP trial

Abstract

Globally populations are ageing and mental health disorders, including dementia and depression, are reported as the leading cause of disability and ill health in older people (1). Epidemiological and randomised trial evidence supports potential roles for folate and the metabolically related B-vitamins in preventing cognitive dysfunction and depression in ageing, but the evidence is inconsistent (2). The aim of this study was to investigate the effect of supplementation with folate and related B-vitamins, over a 2 year period, on cognitive function (primary outcome) and depression (secondary outcome) in older adults. The B-vitamins and Brain Health in Older People (BrainHOP) randomised controlled trial was conducted in adults aged 70 years and older. Participants were randomised to receive a supplement containing folic acid (400 µg), vitamin B12 (10 µg), vitamin B6 (10 mg) and riboflavin (10 mg) or placebo daily. Cognitive function was assessed before and after the 2-year intervention using the Frontal Assessment Battery (FAB) and the Repeatable Battery of the Assessment of Neuropsychological Status (RBANS). Depression was assessed using the Centre for Epidemiological Studies Depression (CES-D) scale. Of the 328 participants initially recruited, 249 (74%) participants completed the intervention. Results showed that B-vitamin intervention appeared to have no significant effect on either frontal lobe or global cognitive function (as measured by FAB and RBANS, respectively). However, when specific domains within global cognition (i.e. RBANS index scores) were examined separately, B-vitamin intervention was found to protect against visuospatial cognitive decline over the two year period (Table).

Efficacy of Vitamins on Cognitive Function of Non-Demented People: A Systematic Review and Meta-Analysis

“…Of these, one was a quasi-experimental pre-test-post-test control group design [22], one was a placebo-controlled trial allocated on matching principle [23], and the others were randomized, placebo-controlled designs. Two were letters to the editor [24,25], one was printed in proceedings [26] and the others were full articles formally published in journals. Sample sizes ranged from 22 to 1053.…”

“…As for the dosage and ingredient of B vitamin supplementation, 13 studies reported the use of folate (400 to 5000 µg), vitamin B6 (3 to 50 mg), and vitamin B12 (20 to 1000 µg) simultaneously [22][23][24]26,[28][29][30][32][33][34][35][36][37], with two of them using riboflavin as well (10 and 25 mg, respectively) [26,29]. Four studies used folate (400 to 5000 µg) and vitamin B12 (25 to 1500 µg) concurrently [27,[38][39][40].…”

“…After excluding seven studies that were in the form of a letter to the editor or conference proceedings, or were rated as high risk in two or more of the RoB areas [22,23,25,26,29,42,43], overall results did not change (data not shown). After exclusion of six studies that included pre-existing conditions such as cerebrovascular disease and diabetes mellitus [24,[27][28][29]31,58], overall findings did not change except that the effect of B vitamins on global cognition in studies from Asia and the Middle East became significant (SMD −0.76, 95% CI −0.98 to −0.53, n = 320) with an improved statistical heterogeneity (tau 2 = 0.00 and I 2 = 0%).…”

Vitamin Supplementation and Dementia: A Systematic Review

“…Regarding B Complex vitamins, we included a total of 14 studies. In total, eight of them compared B Complex vitamins to placebo [ 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 ], five of them compared B Complex vitamins to conventional treatment [ 45 , 46 , 47 , 48 , 49 ], and one compared vitamin B supplementation with vitamin C supplementation [ 50 ].…”

“…Mean FAB and RBANS scores before and after treatment in intervention and control groups[44]. Participants inMa F. et al.…”