Department of Dermatology, University Hospital of North Norway, Tromsø, Norway.
Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
JAMA Dermatol. 2023 May 1;159(5):518-525. doi: 10.1001/jamadermatol.2023.0357.
Topical vitamin D analogues are routine treatment for psoriasis, but the effect of oral supplementation has not been established.
To examine the effect of vitamin D supplementation on psoriasis severity throughout the winter.
DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind placebo-controlled clinical trial with 2 parallel groups was performed through 2 winter seasons (2017 to 2018 and 2018 to 2019). Randomization was computer generated. All participants, health care clinicians, and outcome assessors were masked to group assignment. Each participant was followed for 4 months. The presented analyses were conducted in May 2022. The trial was conducted at the clinical research unit of the University Hospital of North Norway (Tromsø; Norway). Adults from the general population in Tromsø with active plaque psoriasis and 25-hydroxyvitamin D (25[OH]D) levels of less than 24 ng/mL (to convert to nmol/L, multiply by 2.496) were included.
Vitamin D (cholecalciferol, 100 000 IU, loading dose, followed by 20 000 IU/week) or placebo for 4 months.
Psoriasis Area Severity Index (PASI) (primary outcome), Physician Global Assessment, self-administered PASI, and Dermatology Life Quality Index scores (secondary outcomes).
A total of 122 participants (46 women [37.7%]; mean [SD] age, 53.6 [10.0] years; mean [SD] PASI score, 3.1 [2.0]; mean [SD] serum 25(OH)D, 14.9 [3.9] ng/mL) were included. Of these, 60 (49.2%) were randomized to the vitamin D group and 62 (50.8%) to the placebo group. A total of 120 participants (59 vitamin D [49.2%]/61 placebo [51.8%]) completed the study. By completion, mean (SD) 25(OH)D levels were 29.7 (5.2) ng/mL (vitamin D) and 12.0 (3.8) ng/mL (placebo). There was no significant difference in change in PASI score between the groups (adjusted difference, 0.11; 95% CI, -0.23 to 0.45). There was no significant difference in change in Physician Global Assessment score (adjusted odds ratio, 0.66; 95% CI, 0.27-1.63), self-administered PASI (adjusted difference, -0.60; 95% CI, -1.76 to 0.55) or Dermatology Life Quality Index (adjusted difference, -0.86; 95% CI, -1.9 to 0.19) between the groups. No adverse effects of the intervention were registered.
The results of this randomized clinical trial showed that vitamin D supplementation did not affect psoriasis severity. Low baseline severity scores may explain the lack of measurable effect. Levels of 25(OH)D in the intervention group increased to a less-than-expected degree based on previous experimental data from the same source population, and this may have affected the results.
ClinicalTrials.gov Identifier: NCT03334136.
重要性：局部维生素 D 类似物是治疗银屑病的常规方法，但口服补充的效果尚未确定。
目的：研究维生素 D 补充剂对整个冬季银屑病严重程度的影响。
设计、地点和参与者：这是一项随机、双盲、安慰剂对照的临床试验，分为 2 个平行组，在 2 个冬季（2017 年至 2018 年和 2018 年至 2019 年）进行。随机化由计算机生成。所有参与者、临床医生和结果评估者均对分组情况进行了掩蔽。每个参与者随访 4 个月。所呈现的分析是在 2022 年 5 月进行的。该试验在挪威特罗姆瑟的北挪威大学医院（特罗姆瑟；挪威）的临床研究单位进行。特罗姆瑟的一般人群中患有活跃斑块型银屑病且 25-羟维生素 D（25[OH]D）水平低于 24ng/mL（将结果转换为 nmol/L 时，乘以 2.496）的成年人被纳入研究。
干预措施：维生素 D（胆钙化醇，100000IU，负荷剂量，随后每周 20000IU）或安慰剂治疗 4 个月。
主要结局和测量指标：银屑病面积严重程度指数（PASI）（主要结局）、医生总体评估、自我评估 PASI 和皮肤病生活质量指数评分（次要结局）。
结果：共有 122 名参与者（46 名女性[37.7%]；平均[标准差]年龄 53.6[10.0]岁；平均[标准差]PASI 评分 3.1[2.0]；平均[标准差]血清 25(OH)D 水平 14.9[3.9]ng/mL）被纳入研究。其中，60 名（49.2%）被随机分配至维生素 D 组，62 名（50.8%）被分配至安慰剂组。共有 120 名参与者（59 名维生素 D[49.2%]/61 名安慰剂[51.8%]）完成了研究。完成时，平均（标准差）25(OH)D 水平分别为 29.7（5.2）ng/mL（维生素 D）和 12.0（3.8）ng/mL（安慰剂）。两组间 PASI 评分的变化无显著差异（调整差异，0.11；95%置信区间，-0.23 至 0.45）。两组间医生总体评估评分（调整优势比，0.66；95%置信区间，0.27-1.63）、自我评估 PASI（调整差异，-0.60；95%置信区间，-1.76 至 0.55）或皮肤病生活质量指数（调整差异，-0.86；95%置信区间，-1.9 至 0.19）的变化均无显著差异。未登记干预措施的不良反应。
结论和相关性：这项随机临床试验的结果表明，维生素 D 补充剂并未影响银屑病的严重程度。较低的基线严重程度评分可能解释了无明显效果的原因。根据来自同一来源人群的先前实验数据，干预组 25(OH)D 水平的增加程度低于预期，这可能影响了结果。
试验注册：ClinicalTrials.gov 标识符：NCT03334136。
