Effect of 3-year folic acid supplementation on cognitive function in older adults in the FACIT trial: a randomised, double blind, controlled trial
Effect of 3-year folic acid supplementation on cognitive function in older adults in the FACIT trial: a randomised, double blind, controlled trial
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DOI：
10.1016/s0140-6736(07)60109-3
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发表时间：
2007-01-20
期刊：
影响因子：
168.9
通讯作者：
Verhoef, Petra
中科院分区：
文献类型：
--
作者：
Durga, Jane;van Boxtel, Martin P. J.;Verhoef, Petra
背景：在一般人群中，低叶酸和高同型半胱氨酸浓度与认知能力差有关。作为FACIT试验的一部分，在筛选时血浆总同型半胱氨酸升高且血清维生素B-12正常的50-70岁男性和女性中评估叶酸对动脉粥样硬化标志物的影响，我们在此报告次要终点的结果：叶酸补充剂对认知能力的影响。方法我们的随机，双盲，安慰剂对照研究发生在11月，1999年和2004年12月，在荷兰。我们随机分配818名参与者，每天口服800微克叶酸或安慰剂，为期3年。对认知表现的影响是通过两组在记忆、感觉运动速度、复杂速度、信息处理速度和文字流畅性方面的3年变化来衡量的。该试验在clinicaltrials.gov注册，试验编号为NCT 00110604。结果：与服用安慰剂的受试者相比，服用叶酸的受试者血清叶酸浓度增加576%（95%CI 539 ~ 614），血浆总同型半胱氨酸浓度降低26%（95%CI 24 ~ 28）。记忆的3年变化（Z评分差异0.132，95% CI 0.032 - 0.233），信息处理速度（0.087，0.016至0.158）和感觉运动速度（0.064，-0.001至0.129）在叶酸组中，与安慰剂组相比，有显著性改善。解释补充叶酸3年，认知功能会随着年龄的增长而下降。
Background Low folate and raised homocysteine concentrations in blood are associated with poor cognitive performance in the general population. As part of the FACIT trial to assess the effect of folic acid on markers of atherosclerosis in men and women aged 50-70 years with raised plasma total homocysteine and normal serum vitamin B-12 at screening, we report here the findings for the secondary endpoint: the effect of folic acid supplementation on cognitive performance.Methods Our randomised, double blind, placebo controlled study took place between November, 1999, and December, 2004, in the Netherlands. We randomly assigned 818 participants 800 mu g daily oral folic acid or placebo for 3 years. The effect on cognitive performance was measured as the difference between the two groups in the 3-year change in performance for memory, sensorimotor speed, complex speed, information processing speed, and word fluency. Analysis was by intention-to-treat. This trial is registered with clinicaltrials.gov with trial number NCT00110604.Findings Serum folate concentrations increased by 576% (95% CI 539 to 614) and plasma total homocysteine concentrations decreased by 26% (24 to 28) in participants taking folic acid compared with those taking placebo. The 3-year change in memory (difference in Z scores 0.132, 95% CI 0.032 to 0.233), information processing speed (0.087, 0.016 to 0.158) and sensorimotor speed (0.064, -0.001 to 0.129) were significantly better in the folic acid group than in the placebo group.Interpretation Folic acid supplementation for 3 years significantly improved domains of cognitive function that tend to decline with age.