Swart Karin M A, Ham Annelies C, van Wijngaarden Janneke P, Enneman Anke W, van Dijk Suzanne C, Sohl Evelien, Brouwer-Brolsma Elske M, van der Zwaluw Nikita L, Zillikens M Carola, Dhonukshe-Rutten Rosalie A M, van der Velde Nathalie, Brug Johannes, Uitterlinden André G, de Groot Lisette C P G M, Lips Paul, van Schoor Natasja M
Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.
Department of Internal Medicine, Erasmus MC, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
Calcif Tissue Int. 2016 Jan;98(1):18-27. doi: 10.1007/s00223-015-0059-5. Epub 2015 Sep 28.
Elevated homocysteine concentrations are associated with a decline in physical function in elderly persons. Homocysteine-lowering therapy may slow down this decline. This study aimed to examine the effect of a 2-year intervention of vitamin B12 and folic acid supplementation on physical performance, handgrip strength, and risk of falling in elderly subjects in a double-blind, randomized placebo-controlled trial. Participants aged ≥65 years with elevated plasma homocysteine concentrations [12-50 µmol/L (n = 2919)] were randomly assigned to daily supplementation of 500 µg vitamin B12, 400 µg folic acid, and 600 IU vitamin D3, or to placebo with 600 IU vitamin D3. Physical performance (range 0-12) and handgrip strength (kg) were measured at baseline and after 2 years. Falls were reported prospectively on a research calendar. Intention-to-treat (primary) and per-protocol (secondary) analyses were performed. Physical performance level and handgrip strength significantly decreased during the follow-up period, but this decline did not differ between groups. Moreover, time to first fall was not significantly different (HR: 1.0, 95% CI 0.9-1.2). Secondary analyses on a per-protocol base identified an interaction effect with age on physical performance. In addition, the treatment was associated with higher follow-up scores on the walking test (cumulative OR: 1.3, 95% CI 1.1-1.5). Two-year supplementation of vitamin B12 and folic acid was neither effective in reducing the age-related decline in physical performance and handgrip strength, nor in the prevention of falling in elderly persons. Despite the overall null-effect, the results provide indications for a positive effect of the intervention on gait, as well as on physical performance among compliant persons >80 years. These effects should be further tested in future studies.
同型半胱氨酸浓度升高与老年人身体机能下降有关。降低同型半胱氨酸的疗法可能会减缓这种下降。本研究旨在通过一项双盲、随机、安慰剂对照试验，考察为期2年的维生素B12和叶酸补充干预对老年受试者身体机能、握力及跌倒风险的影响。血浆同型半胱氨酸浓度升高[12 - 50 µmol/L（n = 2919）]的≥65岁参与者被随机分配至每日补充500 µg维生素B12、400 µg叶酸和600 IU维生素D3组，或补充含600 IU维生素D3的安慰剂组。在基线和2年后测量身体机能（范围0 - 12）和握力（kg）。通过研究日历前瞻性报告跌倒情况。进行意向性分析（主要分析）和符合方案分析（次要分析）。随访期间身体机能水平和握力显著下降，但两组间这种下降无差异。此外，首次跌倒时间无显著差异（风险比：1.0，95%置信区间0.9 - 1.2）。基于符合方案的次要分析确定了年龄对身体机能的交互作用。此外，该治疗与步行试验中更高的随访得分相关（累积比值比：1.3，95%置信区间1.1 - 1.5）。为期2年的维生素B12和叶酸补充在减少与年龄相关的身体机能和握力下降方面均无效，在预防老年人跌倒方面也无效。尽管总体无效应，但结果表明该干预对步态以及对80岁以上依从性好的人的身体机能有积极作用。这些效应应在未来研究中进一步验证。
