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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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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

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Vitiligo Vitiligo, Generalized Autoimmune Autoimmune Diseases Autoimmune Disease Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Oral Vitamin D + NB-UVB Phototherapy

Group Type EXPERIMENTAL

Oral Vitamin D

Intervention Type DRUG

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

NB-UVB Phototherapy

Intervention Type 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.

Placebo + NB-UVB Phototherapy

Group Type PLACEBO_COMPARATOR

NB-UVB Phototherapy

Intervention Type 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.

Placebo

Intervention Type DRUG

Administered orally daily for 6 months

Interventions

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Oral Vitamin D

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Placebo

Administered orally daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No