Department of Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.
Neurology. 2011 Oct 25;77(17):1611-8. doi: 10.1212/WNL.0b013e3182343274.
Higher latitude, lower ultraviolet exposure, and lower serum 25-hydroxyvitamin D (25OHD) correlate with higher multiple sclerosis (MS) prevalence, relapse rate, and mortality. We therefore evaluated the effects of high-dose vitamin D2 (D2) in MS.
Adults with clinically active relapsing-remitting MS (RRMS) were randomized to 6 months' double-blind placebo-controlled high-dose vitamin D2, 6,000 IU capsules, dose adjusted empirically aiming for a serum 25OHD 130-175 nM. All received daily low-dose (1,000 IU) D2 to prevent deficiency. Brain MRIs were performed at baseline, 4, 5, and 6 months. Primary endpoints were the cumulative number of new gadolinium-enhancing lesions and change in the total volume of T2 lesions. Secondary endpoints were Expanded Disability Status Scale (EDSS) score and relapses.
Twenty-three people were randomized, of whom 19 were on established interferon or glatiramer acetate (Copaxone) treatment. Median 25OHD rose from 54 to 69 nM (low-dose D2) vs 59 to 120 nM (high-dose D2) (p = 0.002). No significant treatment differences were detected in the primary MRI endpoints. Exit EDSS, after adjustment for entry EDSS, was higher following high-dose D2 than following low-dose D2 (p = 0.05). There were 4 relapses with high-dose D2 vs none with low-dose D2 (p = 0.04).
We did not find a therapeutic advantage in RRMS for high-dose D2 over low-dose D2 supplementation.
This study provides Class I evidence that high-dose vitamin D2 (targeting 25OHD 130-175 nM), compared to low-dose supplementation (1,000 IU/d), was not effective in reducing MRI lesions in patients with RRMS.
较高的纬度、较低的紫外线暴露和较低的血清 25-羟维生素 D（25OHD）与多发性硬化症（MS）的更高患病率、复发率和死亡率相关。因此，我们评估了大剂量维生素 D2（D2）在 MS 中的作用。
患有临床活动型复发缓解型多发性硬化症（RRMS）的成年人被随机分配到 6 个月的双盲安慰剂对照大剂量维生素 D2（6000 IU 胶囊）治疗，经验性调整剂量以达到血清 25OHD 130-175 nM。所有人都接受每日低剂量（1000 IU）D2 以预防缺乏。在基线、4、5 和 6 个月时进行脑 MRI。主要终点是新钆增强病变的累积数量和 T2 病变总体积的变化。次要终点是扩展残疾状况量表（EDSS）评分和复发。
23 人被随机分配，其中 19 人正在接受干扰素或格拉替雷（Copaxone）治疗。中位数 25OHD 从 54 增加到 69 nM（低剂量 D2）与 59 增加到 120 nM（高剂量 D2）（p=0.002）。主要 MRI 终点无显著治疗差异。在调整了进入 EDSS 后，高剂量 D2 后的 EDSS 终点高于低剂量 D2（p=0.05）。高剂量 D2 组有 4 例复发，低剂量 D2 组无复发（p=0.04）。
我们没有发现高剂量 D2 比低剂量 D2 补充在 RRMS 中具有治疗优势。
本研究提供了 I 级证据，表明与低剂量补充（1000 IU/d）相比，高剂量维生素 D2（目标 25OHD 130-175 nM）并不能有效减少 RRMS 患者的 MRI 病变。
