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

NCT04872257 | Completed

• 1 other identifier: DE19-00002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo; Vitiligo, Generalized; Autoimmune; Autoimmune Diseases; Autoimmune Disease Skin

Keywords

vitiligo; randomized clinical trial; vitamin D; phototherapy; quality of life

Outcome Measures

Primary Outcomes (3)

• VASI score - Vitiligo Area and Severity Index (VASI)

  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.

  Week 0

• VASI score - Vitiligo Area and Severity Index (VASI)

  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.

  Week 12

• VASI score - Vitiligo Area and Severity Index (VASI)

  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.

  Week 24

Secondary Outcomes (10)

• VETF score - Vitiligo European Task Force (VETF) score

  Week 0

• VETF score - Vitiligo European Task Force (VETF) score

  Week 12

• VETF score - Vitiligo European Task Force (VETF) score

  Week 24

• Vitamin D blood levels

  Week 0

• Vitamin D blood levels

  Week 12

Study Arms (2)

Oral Vitamin D + NB-UVB Phototherapy

EXPERIMENTAL

Drug: Oral Vitamin D; Procedure: NB-UVB Phototherapy

Placebo + NB-UVB Phototherapy

PLACEBO COMPARATOR

Procedure: NB-UVB Phototherapy; Drug: Placebo

Interventions

Oral Vitamin D DRUG

Vitamin D 5,000 UI for 6 months (oral capsule, daily, single-dose)

Oral Vitamin D + NB-UVB Phototherapy

NB-UVB Phototherapy PROCEDURE

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.

Oral Vitamin D + NB-UVB Phototherapy; Placebo + NB-UVB Phototherapy

Placebo DRUG

Administered orally daily for 6 months

Placebo + NB-UVB Phototherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Vitiligo; Autoimmune Diseases

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Adrian B Cuellar-Barboza, MD

  Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: September 14, 2021
• Primary Completion: February 25, 2022
• Study Completion: November 1, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)