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

Primary Purpose

Vitiligo, Vitiligo, Generalized, Autoimmune

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Oral Vitamin D
NB-UVB Phototherapy
Placebo
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, randomized clinical trial, vitamin D, phototherapy, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Vitamin D + NB-UVB Phototherapy

Placebo + NB-UVB Phototherapy

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
Vitamin D blood levels
Measure vitamin D levels on blood between the intervention and control group
Vitamin D blood levels
Measure vitamin D levels on blood between the intervention and control group
Vitamin D blood levels
Measure vitamin D levels on blood between the intervention and control group
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.
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.
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.
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.

Full Information

First Posted
April 29, 2021
Last Updated
February 13, 2023
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT04872257
Brief Title
Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Vitiligo, Generalized, Autoimmune, Autoimmune Diseases, Autoimmune Disease Skin
Keywords
vitiligo, randomized clinical trial, vitamin D, phototherapy, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Vitamin D + NB-UVB Phototherapy
Arm Type
Experimental
Arm Title
Placebo + NB-UVB Phototherapy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oral Vitamin D
Intervention Description
Vitamin D 5,000 UI for 6 months (oral capsule, daily, single-dose)
Intervention Type
Procedure
Intervention Name(s)
NB-UVB Phototherapy
Intervention Description
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
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally daily for 6 months
Primary Outcome Measure Information:
Title
VASI score - Vitiligo Area and Severity Index (VASI)
Description
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.
Time Frame
Week 0
Title
VASI score - Vitiligo Area and Severity Index (VASI)
Description
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.
Time Frame
Week 12
Title
VASI score - Vitiligo Area and Severity Index (VASI)
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
VETF score - Vitiligo European Task Force (VETF) score
Description
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).
Time Frame
Week 0
Title
VETF score - Vitiligo European Task Force (VETF) score
Description
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).
Time Frame
Week 12
Title
VETF score - Vitiligo European Task Force (VETF) score
Description
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).
Time Frame
Week 24
Title
Vitamin D blood levels
Description
Measure vitamin D levels on blood between the intervention and control group
Time Frame
Week 0
Title
Vitamin D blood levels
Description
Measure vitamin D levels on blood between the intervention and control group
Time Frame
Week 12
Title
Vitamin D blood levels
Description
Measure vitamin D levels on blood between the intervention and control group
Time Frame
Week 24
Title
DLQI - Dermatology Life Quality Index
Description
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.
Time Frame
Week 0
Title
DLQI - Dermatology Life Quality Index
Description
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.
Time Frame
Week 24
Title
VitiQoL - Vitiligo Specific Quality of Life
Description
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.
Time Frame
Week 0
Title
VitiQoL - Vitiligo Specific Quality of Life
Description
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.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian B Cuellar-Barboza, MD
Organizational Affiliation
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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