Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 \[niacin\]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years old or greater;
• Either History of 2 or more histologically confirmed invasive cutaneous SCCs in the past 2 years or
• At least one previously billed Healthcare Common Procedure Coding System code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system);
• Understands, reads, and writes English proficiently.
Locations
United States
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Contact Information
Primary
Eunyoung Cho, ScD
Eunyoung_Cho@brown.edu
401-863-5895
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 30
Treatments
Experimental: Vitamin A & Nicotinamide
1,000 μg retinyl palmitate and 500 mg NAM twice a day
Placebo_comparator: Placebo
Identical placebo pills twice a day
Related Therapeutic Areas
Sponsors
Leads: Rhode Island Hospital