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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    30
  • sponsor
    The Cleveland Clinic
Updated on 25 January 2021
aminolevulinic acid
photodynamic therapy
vitamin d
vitamin d supplementation

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).

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.

Details
Condition Actinic keratosis
Treatment Vitamin D 10000 UNT
Clinical Study IdentifierNCT04482322
SponsorThe Cleveland Clinic
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older
At least 10 AK lesions on the face

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
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