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

Actinic Keratoses Clinical Trial

— VDAK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482322
• Other study ID #: 19-1371
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2020
• Source: The Cleveland Clinic
• Contact: Jeffrey Negrey, MA
• Phone: 216-636-5504
• Email: negreyj2[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Dietary Supplement:
• Vitamin D 10000 UNT
Patients will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actinic Keratosis (AK) clearance	Is there any correlation between providing supplementation with 10,000 IU of Vitamin D, and the rate of AK lesion clearance post-PDT (anticipate improved clearance).	3 month follow up
Secondary	Vitamin D receptor (VDR) allelic status and PDT treatment outcome	Is there any correlation between the Fok1 allele or the poly-A allele of the Vitamin D receptor (VDR), and AK lesion clearance after PDT?	3 month follow up