Nowak Albina, Boesch Lukas, Andres Erik, Battegay Edouard, Hornemann Thorsten, Schmid Christoph, Bischoff-Ferrari Heike A, Suter Paolo M, Krayenbuehl Pierre-Alexandre
Department of Internal Medicine Institute for Clinical Chemistry, University Hospital Zurich and University of Zurich Division of Endocrinology, Diabetology and Clinical Nutrition Department of Geriatrics, University Hospital Zurich, Zurich Department of Internal Medicine, Spital Linth, Uznach, Switzerland.
Medicine (Baltimore). 2016 Dec;95(52):e5353. doi: 10.1097/MD.0000000000005353.
Vitamin D deficiency is frequent and has been associated with fatigue in uncontrolled trials.
This is the first double-blind placebo-controlled clinical trial to investigate the efficacy of per os vitamin D3 (cholecalciferol) in treating fatigue among otherwise healthy persons with low serum 25-hydroxyvitamin D (25(OH)D) levels. We enrolled 120 individuals (mean age 29 ± 6 years, 53% women) presenting with fatigue and vitamin D deficiency (serum 25(OH)D < 20 μg/L). Participants were randomized to a single oral dose of 100,000 units of vitamin D or placebo. The primary endpoint was intra-individual change in the fatigue assessment scale (FAS) at 4 weeks after treatment.
The mean age of the participants was 29 ± 6 years, 53% were women. Mean FAS decreased significantly more in the vitamin D group (-3.3 ± 5.3; 95% confidence interval [CI] for change -14.1 to 4.1) compared with placebo (-0.8 ± 5.3; 95% CI for change -9.0 to 8.7); (P = 0.01). Amelioration of fatigue was reported more frequently in vitamin D than in placebo group (42 [72%] vs. 31 [50%]; P = 0.01; odds ratio [OR] 2.63, 95% CI for OR 1.23-5.62). Among all participants, improvement in fatigue score correlated with the rise in 25(OH)D level (R = -0.22, P = 0.02).
Vitamin D treatment significantly improved fatigue in otherwise healthy persons with vitamin D deficiency.This study was registered at the www.ClinicalTrials.gov Protocol ID NCT02022475.
维生素D缺乏症很常见，在非对照试验中，它与疲劳有关。
这是第一项双盲安慰剂对照临床试验，旨在研究口服维生素D3（胆钙化醇）对血清25-羟基维生素D（25(OH)D）水平较低的健康人群疲劳症状的治疗效果。我们招募了120名出现疲劳症状且维生素D缺乏（血清25(OH)D<20μg/L）的个体（平均年龄29±6岁，53%为女性）。参与者被随机分为两组，分别单次口服100,000单位维生素D或安慰剂。主要终点是治疗4周后疲劳评估量表（FAS）的个体内变化。
参与者的平均年龄为29±6岁，53%为女性。与安慰剂组（-0.8±5.3；变化的95%置信区间[CI]为-9.0至8.7）相比，维生素D组的平均FAS显著下降更多（-3.3±5.3；变化的95%CI为-14.1至4.1）；（P=0.01）。报告称，维生素D组疲劳症状改善的频率高于安慰剂组（42例[72%]对31例[50%]；P=0.01；优势比[OR]2.63，OR的95%CI为1.23-5.62）。在所有参与者中，疲劳评分的改善与25(OH)D水平的升高相关（R=-0.22，P=0.02）。
维生素D治疗显著改善了维生素D缺乏的健康人群的疲劳症状。本研究已在www.ClinicalTrials.gov注册，试验注册号为NCT02022475。
