Clinical trial NCT04872257: Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo
Official title: Combined Therapy With NB-UVB Phototherapy and Oral Vitamin D Supplementation in Patients With Vitiligo: a Randomized-clinical Trial, Triple-blind, Placebo-controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Vitiligo, Generalized
Autoimmune
Autoimmune Diseases
Autoimmune Disease Skin
Keywords: vitiligo
randomized clinical trial
vitamin D
phototherapy
quality of life
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: VASI score - Vitiligo Area and Severity Index (VASI)
timeFrame: Week 0
measure: VASI score - Vitiligo Area and Severity Index (VASI)
timeFrame: Week 12
measure: VASI score - Vitiligo Area and Severity Index (VASI)
timeFrame: Week 24
Secondary outcomes:
measure: VETF score - Vitiligo European Task Force (VETF) score
timeFrame: Week 0
measure: VETF score - Vitiligo European Task Force (VETF) score
timeFrame: Week 12
measure: VETF score - Vitiligo European Task Force (VETF) score
timeFrame: Week 24
measure: Vitamin D blood levels
timeFrame: Week 0
measure: Vitamin D blood levels
timeFrame: Week 12
measure: Vitamin D blood levels
timeFrame: Week 24
measure: DLQI - Dermatology Life Quality Index
timeFrame: Week 0
measure: DLQI - Dermatology Life Quality Index
timeFrame: Week 24
measure: VitiQoL - Vitiligo Specific Quality of Life
timeFrame: Week 0
measure: VitiQoL - Vitiligo Specific Quality of Life
timeFrame: Week 24
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
name: Adrian B Cuellar-Barboza, MD
role: PRINCIPAL_INVESTIGATOR
References: