Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo

Hospital Universitario Dr. Jose E. Gonzalez

Status

Completed

Conditions

Vitiligo, Generalized

Autoimmune Disease Skin

Vitiligo

Autoimmune

Autoimmune Diseases

Treatments

Procedure: NB-UVB Phototherapy

Drug: Placebo

Drug: Oral Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT04872257

DE19-00002

Details and patient eligibility

About

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.

Full 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).

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.