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Results of 2-year vitamin B treatment on cognitive performance: secondary data from an RCT.

Neurology (2014-11-14)
Nikita L van der Zwaluw, Rosalie A M Dhonukshe-Rutten, Janneke P van Wijngaarden, Elske M Brouwer-Brolsma, Ondine van de Rest, Paulette H In 't Veld, Anke W Enneman, Suzanne C van Dijk, Annelies C Ham, Karin M A Swart, Nathalie van der Velde, Natasja M van Schoor, Tischa J M van der Cammen, André G Uitterlinden, Paul Lips, Roy P C Kessels, Lisette C P G M de Groot
ABSTRACT

We investigated the effects of 2-year folic acid and vitamin B12 supplementation on cognitive performance in elderly people with elevated homocysteine (Hcy) levels. 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). 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. 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. 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.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Cyanocobalamin, tested according to Ph. Eur.
Sigma-Aldrich
Folic acid, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥97%
Sigma-Aldrich
Folic acid, ≥97%
Sigma-Aldrich
Cyanocobalamin, meets USP testing specifications
Sigma-Aldrich
Folic acid, meets USP testing specifications
Supelco
Folic acid, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Cyanocobalamin (B12), analytical standard
Supelco
Cyanocobalamin (Vitamin B12) solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Cyanocobalamin, European Pharmacopoeia (EP) Reference Standard
Supelco
Cyanocobalamin, pharmaceutical secondary standard, certified reference material
USP
Folic acid, United States Pharmacopeia (USP) Reference Standard
Folic acid, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Vitamin B12, ≥98%
Sigma-Aldrich
Vitamin B12, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥98%