Combined Therapy With NB-UVB Phototherapy and Oral Vitamin D Supplementation in Patients With Vitiligo: a Randomized-clinical Trial, Triple-blind, Placebo-controlled
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- VASI score - Vitiligo Area and Severity Index (VASI)
研究概览
简要总结
A randomized clinical trial that treats vitiligo patients with oral vitamin D and Narrow-Band Ultraviolet B (NB-UVB) phototherapy (intervention group); or placebo and NB-UVB phototherapy (control group). We will evaluate if the group supplemented with vitamin D achieves a higher repigmentation rate than the control group, proving the relevance of vitamin D as an immunomodulator in the pathophysiology of vitiligo. These findings may support the use of vitamin D as an economic, safe, and adjuvant treatment for vitiligo.
详细描述
A randomized clinical trial, triple-blind, placebo-controlled treating patients with diagnosed vitiligo. The intervention group will be treated with oral vitamin D 5,000 IU per day and NB-UVB phototherapy. The control group will be treated with placebo and NB-UVB phototherapy. We will evaluate the efficacy (repigmentation rate) and improvement of the quality of life with vitamin D and phototherapy versus placebo and phototherapy.
Our objectives are:
- Evaluate if the use of the supplementation with oral vitamin D accelerates the repigmentation rate in vitiligo lesions treated with NB-UVB phototherapy, achieving a lower accumulated dose of phototherapy.
- Compare basal blood levels of vitamin D before and after treatment completion.
- Compare quality of life of the intervention group with the control group.
- Associate pigmentation rates between intervention and control group obtained with tools that assess activity of disease, such as, Vitiligo Area and Severity Index (VASI) and Vitiligo European Task Force (VETF) score.
- Compare results in quality of life between intervention and control group obtained with tools, such as, Vitiligo-Specific Quality-of-Life Instrument (VitiQoL) and Dermatology Life Quality Index (DLQI).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Our randomization and blinding process is in charge by a nurse who is not part of the study. A pharmacy school laboratory (not part of the study) randomly assigned the intervention and placebo to each patient (1-20) as treatment A or B. This information was delivered in a sealed envelope, in which only the nurse had access to. Neither the participants, investigators and outcome assessor, nor the data analyst know which patient is receiving the experimental treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ≥ 18 years of age at the time of signing the informed consent document.
- •≥5% of affected skin area
- •Inactive, generalized vitiligo (inactive for a minimum of 6 months). [Inactive: No new spontaneous lesions or a rapid progression of these.]
- •Subjects who have not been treated with phototherapy previously.
- •Subject who have not been treated with topical corticosteroids for at least 8 weeks or immunomodulators for at least 12 weeks.
排除标准
- •Subjects with <5% of affected skin area
- •Subjects who use multivitamins, diuretics, lipase-inhibitors (orlistat)
- •Subjects with calcium disorders (for example: primary hyperparathyroidism) or patients with hepatic/kidney failure.
- •Subjects with malabsorption gastrointestinal disorders
- •Pregnant women or in lactation
- •Subjects with cancer
- •Subjects with previous history of skin cancer (melanoma/non-melanoma)
- •Photo-sensible diseases (actinic dermatitis, porphyria, xeroderma pigmentosa) or drugs
- •Subjects using immunomodulator o immunosuppressor treatments
- •Subjects who practice activities that require prolonged sun exposure.
研究组 & 干预措施
Oral Vitamin D + NB-UVB Phototherapy
干预措施: Oral Vitamin D (Drug)
Oral Vitamin D + NB-UVB Phototherapy
干预措施: NB-UVB Phototherapy (Procedure)
Placebo + NB-UVB Phototherapy
干预措施: NB-UVB Phototherapy (Procedure)
Placebo + NB-UVB Phototherapy
干预措施: Placebo (Drug)
结局指标
主要结局
VASI score - Vitiligo Area and Severity Index (VASI)
时间窗: Week 24
The VASI score is used to assess the severity and extent of Vitiligo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
次要结局
- VETF score - Vitiligo European Task Force (VETF) score(Week 24)
- DLQI - Dermatology Life Quality Index(Week 24)
- Vitamin D blood levels(Week 24)
- VitiQoL - Vitiligo Specific Quality of Life(Week 24)
研究者
Jorge Valdespino Valdes
MD
Hospital Universitario Dr. Jose E. Gonzalez