Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses

Last updated: July 21, 2020
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Keratoses

Treatment

N/A

Clinical Study ID

NCT04482322
19-1371
  • Ages > 18
  • All Genders

Study Summary

This is a prospective clinical trial in which 30 patients will receive a brief (5-day or 14-day) supplementation with 10,000 IU of Vitamin D, prior to receiving aminolevulinic acid (ALA)- blue light PDT for the treatment of actinic keratoses (AKs).

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  • Age 18 years or older

  • At least 10 AK lesions on the face

Exclusion

EXCLUSION CRITERIA:

  • Pregnant or nursing

  • At risk for hypercalcemia (renal disease or sarcoidosis)

  • Has taken Vitamin D (includes multivitamins with Vitamin D) within past 1 month

  • Is currently receiving treatment for other cancers

  • Has a known hypersensitivity to aminolevulinic acid

  • Has a known history of a photosensitivity disease, such as porphyria

  • Is currently participating in another clinical trial

Study Design

Total Participants: 30
Study Start date:
January 13, 2020
Estimated Completion Date:
December 31, 2022

Study Description

This is a phase 2 clinical trial of patients with actinic keratosis (AK) that will examine a combination regimen of Vitamin D plus PDT, and compare its efficacy to controls who underwent PDT alone in a prior study from the Maytin group (IRB 16-1615). Patients will be enrolled at the Cleveland Clinic. Each patient will be matched to patients from the prior study based upon baseline calcidiol levels.

Connect with a study center

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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