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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: Vitamin D

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.