Vitamin D Supplementation in Patients With Vitiligo Induced Additive Effects With Phototherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
This prospective, randomized, controlled study was approved by the Institutional Review Board of Hallym University Kangnam Sacred Heart Hospital (IRB no. 2018-04-017). All study participants consented the study and agreed the written informed consent. All participants who are applicable to the inclusion criteria were randomly assigned to two groups: the control group and the study group. Both groups were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). Study group had vitamin D supplementation through the injection additionally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients diagnosed with non-segmental vitiligo based on clinical diagnosis.
- •patients who were ≥ 18 years old.
- •patients with lower serum vitamin D level (<20ng/mL).
排除标准
- •patients taking medicines such as thiazide, diuretics, lithium which can influence the serum vitamin D level.
- •pregnant or lactating women.
- •patients with diseases which can affect kidney such as chronic kidney disease, hyperparathyroidism, or hypoparathyroidism.
- •patients with uncontrolled chronic diseases like diabetes mellitus, hyperlipidemia, hypertension
- •patients whose spot urine calcium level was over 30mg/dL.
研究组 & 干预措施
Study group
They were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). They had vitamin D supplementation through the injection of cholecalciferol additionally. The study group with vitamin D deficiency was treated with intramuscular injection of 200,000 IU cholecalciferol (Kwangdong Pharmaceutical Co., Seoul, Korea) once at baseline. Total study period was 6 months and the clinical assessments with checking adverse events were conducted every month.
干预措施: cholecalciferol (vitamin D3) (Drug)
Study group
They were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). They had vitamin D supplementation through the injection of cholecalciferol additionally. The study group with vitamin D deficiency was treated with intramuscular injection of 200,000 IU cholecalciferol (Kwangdong Pharmaceutical Co., Seoul, Korea) once at baseline. Total study period was 6 months and the clinical assessments with checking adverse events were conducted every month.
干预措施: Phototherapy (Procedure)
Control group
They were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). Total study period was 6 months and the clinical assessments with checking adverse events were conducted every month.
干预措施: Phototherapy (Procedure)
结局指标
主要结局
Vitiligo Area Scoring Index (VASI)
时间窗: 6 month
Each VASI score was decided by multiplying the area of vitiligo and the extent of depigmentation.
次要结局
- Physician global assessment (PGA)(6 month)
研究者
Bo Young Chung
Principal Investigator, Clinical Professor
Hallym University Kangnam Sacred Heart Hospital