VitiligoNCT04872257
Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo
A study testing Oral Vitamin D and NB-UVB Phototherapy in people with Vitiligo and Vitiligo, Generalized, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, Vitiligo, Generalized, Autoimmune
- What is being tested?
- Oral Vitamin D and NB-UVB Phototherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteMexico
- Study dates
- 14 Sep 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
About this study
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
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.
Read the 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).
- Being tested
- Oral Vitamin D, NB-UVB Phototherapy, Placebo
- Keywords
- vitiligo, randomized clinical trial, vitamin D, phototherapy, quality of life
- Medical subject headings
- Vitiligo, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Vitamin DDrug
Vitamin D 5,000 UI for 6 months (oral capsule, daily, single-dose)
NB-UVB PhototherapyProcedure or surgery
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.
PlaceboDrug
Administered orally daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Oral Vitamin D + NB-UVB Phototherapy | Experimental | Not described Receives: Drug: Oral Vitamin D; Procedure: NB-UVB Phototherapy |
| Placebo + NB-UVB Phototherapy | Placebo comparator | Not described Receives: Procedure: NB-UVB Phototherapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 24
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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).
Measured: Week 24
Vitamin D blood levels
Measure vitamin D levels on blood between the intervention and control group
Measured: Week 0
Vitamin D blood levels
Measure vitamin D levels on blood between the intervention and control group
Measured: Week 12
Vitamin D blood levels
Measure vitamin D levels on blood between the intervention and control group
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start14 Sep 2021
- Primary completion25 Feb 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Valdespino Valdes, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Adrian B Cuellar-Barboza, MD, Principal investigator, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872257
- Sponsor's protocol ID
- DE19-00002
- Status last verified
- Feb 2023
- First submitted
- 29 Apr 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04872257
- Acronym / sponsor ID
- DE19-00002
- Keywords
- vitiligo, randomized clinical trial, vitamin D, phototherapy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Vitamin DVitamin D 5,000 UI for 6 months (oral capsule, daily, single-dose) | Drug | Oral Vitamin D + NB-UVB Phototherapy |
| NB-UVB PhototherapyNB-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. | Procedure or surgery | Oral Vitamin D + NB-UVB Phototherapy, Placebo + NB-UVB Phototherapy |
| PlaceboAdministered orally daily for 6 months | Drug | Placebo + NB-UVB Phototherapy |
Primary outcome
VASI score - Vitiligo Area and Severity Index (VASI)
Time frame: Week 0
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)
Time frame: Week 12
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)
Time frame: Week 24
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.
10 secondary outcomes
VETF score - Vitiligo European Task Force (VETF) score
Time frame: Week 0
VETF score - Vitiligo European Task Force (VETF) score
Time frame: Week 12
VETF score - Vitiligo European Task Force (VETF) score
Time frame: Week 24
Vitamin D blood levels
Time frame: Week 0
Vitamin D blood levels
Time frame: Week 12
Vitamin D blood levels
Time frame: Week 24
DLQI - Dermatology Life Quality Index
Time frame: Week 0
DLQI - Dermatology Life Quality Index
Time frame: Week 24
VitiQoL - Vitiligo Specific Quality of Life
Time frame: Week 0
VitiQoL - Vitiligo Specific Quality of Life
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian B Cuellar-Barboza, MD principal investigator
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Vitamin D and NB-UVB Phototherapy in people with Vitiligo and Vitiligo, Generalized, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VASI score - Vitiligo Area and Severity Index (VASI) (time frame: Week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.