Status:
COMPLETED
Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Vitiligo
Vitiligo, Generalized
Eligibility:
All Genders
18+ years
Phase:
NA
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 grou...
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 photothe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04872257
Start Date
September 14 2021
End Date
November 1 2022
Last Update
February 14 2023
Active Locations (1)
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1
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico, 64460