NCT04872257

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

Combined Therapy With NB-UVB Phototherapy and Oral Vitamin D Supplementation in Patients With Vitiligo: a Randomized-clinical Trial, Triple-blind, Placebo-controlled

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Vitiligo
• Vitiligo, Generalized
• Autoimmune
• Autoimmune Diseases
• Autoimmune Disease Skin

Interventions

Type	Name	Description
DRUG	Oral Vitamin D	Vitamin D 5,000 UI for 6 months (oral capsule, daily, single-dose)
PROCEDURE	NB-UVB Phototherapy	NB-UVB Phototherapy twice per week for 6 months until completing 48 sessions. Initial dose of 200 mJ/cm² with a 10-20% increase to the previous session. Maximum dose for face and neck is 1500 mJ/cm² and 3000 mJ/cm² for the rest of the body.
DRUG	Placebo	Administered orally daily for 6 months

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-02-25
• Completion: 2022-11-01
• First posted: 2021-05-04
• Last updated: 2023-02-14

Locations

1 site across 1 country: Mexico