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

Study Overview
=================
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).

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

Conditions
-----------------
Vitiligo, Vitiligo, Generalized, Autoimmune, Autoimmune Diseases, Autoimmune Disease Skin

Intervention / Treatment
-----------------
* Drug: Oral Vitamin D
* Procedure: NB-UVB Phototherapy
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Vitamin D + NB-UVB Phototherapy<br> | Drug: Oral Vitamin D<br>* Vitamin D 5,000 UI for 6 months (oral capsule, daily, single-dose)<br>Procedure: NB-UVB Phototherapy<br>* 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.<br>|
| Placebo Comparator: Placebo + NB-UVB Phototherapy<br> | Procedure: NB-UVB Phototherapy<br>* 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.<br>Drug: Placebo<br>* Administered orally daily for 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VETF score - Vitiligo European Task Force (VETF) score | The VETF is a validated scoring system that assesses 3 dimensions of the disease (extent, staging, and spreading/progression). (1) the extent of vitiligo will be estimated as the percentage of vitiligo involvement of 5 body sites. (2) Stage of vitiligo will be assessed as 0 (normal pigmentation), 1 (incomplete depigmentation), 2 (complete depigmentation), 3 (partial hair whitening [<30%]), and 4 (complete hair whitening). (3) Spreading of vitiligo will be scored as 0 (stable disease), -1 (observed ongoing subclinical repigmentation), and +1 (additional patches in a given area or observed ongoing subclinical depigmentation). The VETF score calculated as follows: VETF Extent or Staging or Spreading = Sum of all specific values for that category from all body sites (% of Area affected for Extent; 0-20 for Staging; -5 to +5 for Spreading). | Week 0 | 
| VETF score - Vitiligo European Task Force (VETF) score | The VETF is a validated scoring system that assesses 3 dimensions of the disease (extent, staging, and spreading/progression). (1) the extent of vitiligo will be estimated as the percentage of vitiligo involvement of 5 body sites. (2) Stage of vitiligo will be assessed as 0 (normal pigmentation), 1 (incomplete depigmentation), 2 (complete depigmentation), 3 (partial hair whitening [<30%]), and 4 (complete hair whitening). (3) Spreading of vitiligo will be scored as 0 (stable disease), -1 (observed ongoing subclinical repigmentation), and +1 (additional patches in a given area or observed ongoing subclinical depigmentation). The VETF score calculated as follows: VETF Extent or Staging or Spreading = Sum of all specific values for that category from all body sites (% of Area affected for Extent; 0-20 for Staging; -5 to +5 for Spreading). | Week 12 | 
| VETF score - Vitiligo European Task Force (VETF) score | The VETF is a validated scoring system that assesses 3 dimensions of the disease (extent, staging, and spreading/progression). (1) the extent of vitiligo will be estimated as the percentage of vitiligo involvement of 5 body sites. (2) Stage of vitiligo will be assessed as 0 (normal pigmentation), 1 (incomplete depigmentation), 2 (complete depigmentation), 3 (partial hair whitening [<30%]), and 4 (complete hair whitening). (3) Spreading of vitiligo will be scored as 0 (stable disease), -1 (observed ongoing subclinical repigmentation), and +1 (additional patches in a given area or observed ongoing subclinical depigmentation). The VETF score calculated as follows: VETF Extent or Staging or Spreading = Sum of all specific values for that category from all body sites (% of Area affected for Extent; 0-20 for Staging; -5 to +5 for Spreading). | Week 24 | 
| Vitamin D blood levels | Measure vitamin D levels on blood between the intervention and control group | Week 0 | 
| Vitamin D blood levels | Measure vitamin D levels on blood between the intervention and control group | Week 12 | 
| Vitamin D blood levels | Measure vitamin D levels on blood between the intervention and control group | Week 24 | 
| DLQI - Dermatology Life Quality Index | The DLQI is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions, and its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomized controlled trials in dermatology. | Week 0 | 
| DLQI - Dermatology Life Quality Index | The DLQI is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions, and its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomized controlled trials in dermatology. | Week 24 | 
| VitiQoL - Vitiligo Specific Quality of Life | VitiQoL is an instrument specific for vitiligo that consists of 16 items, in which the patient perceives the severity of their disease and how it affects their quality of life. | Week 0 | 
| VitiQoL - Vitiligo Specific Quality of Life | VitiQoL is an instrument specific for vitiligo that consists of 16 items, in which the patient perceives the severity of their disease and how it affects their quality of life. | Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitiligo, randomized clinical trial, vitamin D, phototherapy, quality of life