Nikita L van der Zwaluw1, Rosalie A M Dhonukshe-Rutten2, Janneke P van Wijngaarden1, Elske M Brouwer-Brolsma1, Ondine van de Rest1, Paulette H In 't Veld1, Anke W Enneman1, Suzanne C van Dijk1, Annelies C Ham1, Karin M A Swart1, Nathalie van der Velde1, Natasja M van Schoor1, Tischa J M van der Cammen1, André G Uitterlinden1, Paul Lips1, Roy P C Kessels1, Lisette C P G M de Groot1. 1. From the Division of Human Nutrition (N.L.v.d.Z., R.A.M.D.-R., J.P.v.W., E.M.B.-B., O.v.d.R., P.H.I.t.V., L.C.P.G.M.d.G.), Wageningen University; Department of Internal Medicine (A.W.E., S.C.v.D., A.C.H., N.v.d.V., T.J.M.v.d.C., A.G.U.), Erasmus University Medical Center, Rotterdam; Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research (K.M.A.S., N.M.v.S., P.L.), and Department of Internal Medicine, Endocrine Section (P.L.), VU University Medical Center, Amsterdam; Radboud Alzheimer Center (R.P.C.K.) and Department of Medical Psychology (R.P.C.K.), Radboud University Medical Center, Nijmegen; and Donders Institute for Brain, Cognition and Behavior (R.P.C.K.), Radboud University Nijmegen, the Netherlands. 2. From the Division of Human Nutrition (N.L.v.d.Z., R.A.M.D.-R., J.P.v.W., E.M.B.-B., O.v.d.R., P.H.I.t.V., L.C.P.G.M.d.G.), Wageningen University; Department of Internal Medicine (A.W.E., S.C.v.D., A.C.H., N.v.d.V., T.J.M.v.d.C., A.G.U.), Erasmus University Medical Center, Rotterdam; Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research (K.M.A.S., N.M.v.S., P.L.), and Department of Internal Medicine, Endocrine Section (P.L.), VU University Medical Center, Amsterdam; Radboud Alzheimer Center (R.P.C.K.) and Department of Medical Psychology (R.P.C.K.), Radboud University Medical Center, Nijmegen; and Donders Institute for Brain, Cognition and Behavior (R.P.C.K.), Radboud University Nijmegen, the Netherlands. Rosalie.Dhonukshe-Rutten@wur.nl.
Abstract
OBJECTIVE: We investigated the effects of 2-year folic acid and vitamin B12 supplementation on cognitive performance in elderly people with elevated homocysteine (Hcy) levels. METHODS: This multicenter, double-blind, randomized, placebo-controlled trial included 2,919 elderly participants (65 years and older) with Hcy levels between 12 and 50 µmol/L. Participants receiveddaily either a tablet with 400 µg folic acid and 500 µg vitamin B12 (B-vitamin group) or a placebo tablet. Both tablets contained 15 µg vitamin D3. Data were available for global cognitive functioning assessed by Mini-Mental State Examination (n = 2,556), episodic memory (n = 2,467), attention and working memory (n = 759), information processing speed (n = 731), and executive function (n = 721). RESULTS:Mean age was 74.1 (SD 6.5) years. Hcy concentrations decreased 5.0 (95% confidence interval -5.3 to -4.7) µmol/L in the B-vitamin group and 1.3 (-1.6 to -0.9) µmol/L in the placebo group. Cognitive domain scores did not differ over time between the 2 groups, as determined by analysis of covariance. Mini-Mental State Examination score decreased with 0.1 (-0.2 to 0.0) in the B-vitamin group and 0.3 (-0.4 to -0.2) in the placebo group (p = 0.05), as determined by an independent t test. CONCLUSIONS: Two-year folic acid and vitamin B12 supplementation did not beneficially affect performance on 4 cognitive domains in elderly people with elevated Hcy levels. It may slightly slow the rate of decline of global cognition, but the reported small difference may be attributable to chance. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that 2-year supplementation with folic acid and vitamin B12 in hyperhomocysteinemic elderly people does not affect cognitive performance.
RCT Entities:
OBJECTIVE: We investigated the effects of 2-year folic acid and vitamin B12 supplementation on cognitive performance in elderly people with elevated homocysteine (Hcy) levels. METHODS: This multicenter, double-blind, randomized, placebo-controlled trial included 2,919 elderly participants (65 years and older) with Hcy levels between 12 and 50 µmol/L. Participants received daily either a tablet with 400 µg folic acid and 500 µg vitamin B12 (B-vitamin group) or a placebo tablet. Both tablets contained 15 µg vitamin D3. Data were available for global cognitive functioning assessed by Mini-Mental State Examination (n = 2,556), episodic memory (n = 2,467), attention and working memory (n = 759), information processing speed (n = 731), and executive function (n = 721). RESULTS: Mean age was 74.1 (SD 6.5) years. Hcy concentrations decreased 5.0 (95% confidence interval -5.3 to -4.7) µmol/L in the B-vitamin group and 1.3 (-1.6 to -0.9) µmol/L in the placebo group. Cognitive domain scores did not differ over time between the 2 groups, as determined by analysis of covariance. Mini-Mental State Examination score decreased with 0.1 (-0.2 to 0.0) in the B-vitamin group and 0.3 (-0.4 to -0.2) in the placebo group (p = 0.05), as determined by an independent t test. CONCLUSIONS: Two-year folic acid and vitamin B12 supplementation did not beneficially affect performance on 4 cognitive domains in elderly people with elevated Hcy levels. It may slightly slow the rate of decline of global cognition, but the reported small difference may be attributable to chance. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that 2-year supplementation with folic acid and vitamin B12 in hyperhomocysteinemic elderly people does not affect cognitive performance.
Authors: Anne Ws Rutjes; David A Denton; Marcello Di Nisio; Lee-Yee Chong; Rajesh P Abraham; Aalya S Al-Assaf; John L Anderson; Muzaffar A Malik; Robin Wm Vernooij; Gabriel Martínez; Naji Tabet; Jenny McCleery Journal: Cochrane Database Syst Rev Date: 2018-12-17
Authors: Jenny McCleery; Rajesh P Abraham; David A Denton; Anne Ws Rutjes; Lee-Yee Chong; Aalya S Al-Assaf; Daniel J Griffith; Shireen Rafeeq; Hakan Yaman; Muzaffar A Malik; Marcello Di Nisio; Gabriel Martínez; Robin Wm Vernooij; Naji Tabet Journal: Cochrane Database Syst Rev Date: 2018-11-01