Oral folic acid and vitamin B-12 supplementation to prevent cognitive decline in community-dwelling older adults with depressive symptoms--the Beyond Ageing Project: a randomized controlled trial.
What this study found
Daily folic acid plus vitamin B-12 improved overall cognitive performance and memory over 24 months compared with placebo, but did not improve other cognitive domains. The omnibus time-by-intervention effect for TICS-M total score was significant (F 2,788.4 = 5.26, P = 0.005), and TICS-M total score increased more from baseline to 24 months in the supplement group than placebo (P = 0.032, effect size = 0.17). Immediate recall also improved more (P = 0.046, effect size = 0.15), as did delayed recall (P = 0.013, effect size = 0.18); the 12-month comparison was not significant (P = 0.283).…
- Study & population
- Randomized controlled factorial trial in community-dwelling adults aged 60 to 74 years with elevated psychological distress and without dementia, recruited in Australia.
- Intervention
- Daily oral folic acid plus vitamin B-12 was given as one tablet containing 400 μg folic acid and 100 μg vitamin B-12 for 24 months.
- Key limitation
- Per-arm sample size was not reported, and sex and other demographic details were limited.
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Open PDFOriginal abstract
BACKGROUND Evidence remains unclear as to whether folic acid (FA) and vitamin B-12 supplementation is effective in reducing depressive symptoms. OBJECTIVES The objective was to determine whether oral FA + vitamin B-12 supplementation prevented cognitive decline in a cohort of community-dwelling older adults with elevated psychological distress. DESIGN A randomized controlled trial (RCT) with a completely crossed 2 × 2 × 2 factorial design comprising daily oral 400 μg FA + 100 μg vitamin B-12 supplementation (compared with placebo), physical activity promotion, and depression literacy with comparator control interventions for reducing depressive symptoms was conducted in 900 adults aged 60-74 y with elevated psychological distress (Kessler Distress 10-Scale; scores >15). The 2-y intervention was delivered in 10 modules via mail with concurrent telephone tracking calls. Main outcome measures examined change in cognitive functioning at 12 and 24 mo by using the Telephone Interview for Cognitive Status-Modified (TICS-M) and the Brief Test of Adult Cognition by Telephone (processing speed); the Informant Questionnaire on Cognitive Decline in the Elderly was administered at 24 mo. RESULTS FA + vitamin B-12 improved the TICS-M total (P = 0.032; effect size d = 0.17), TICS-M immediate (P = 0.046; d = 0.15), and TICS-M delayed recall (P = 0.013; effect size d = 0.18) scores at 24 mo in comparison with placebo. No significant changes were evident in orientation, attention, semantic memory, processing speed, or informant reports. CONCLUSION Long-term supplementation of daily oral 400 μg FA + 100 μg vitamin B-12 promotes improvement in cognitive functioning after 24 mo, particularly in immediate and delayed memory performance. This trial was registered at clinicaltrials.gov as NCT00214682.