Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo (NCT04872257) | Clinical Trial Compass
CompletedNot Applicable
Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo
Mexico26 participantsStarted 2021-09-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VASI score - Vitiligo Area and Severity Index (VASI)
Timeframe: Week 0
2
VASI score - Vitiligo Area and Severity Index (VASI)
Timeframe: Week 12
3
VASI score - Vitiligo Area and Severity Index (VASI)
Timeframe: Week 24
Trial details
NCT IDNCT04872257
SponsorHospital Universitario Dr. Jose E. Gonzalez