RecruitingEarly Phase 1NCT05702398

Pilot Trial of Supplemental Vitamin A and Nicotinamide

Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide

Sponsor

Rhode Island Hospital

Enrollment

30 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Skin Cancer Kidney Transplant Recipients

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

Min Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria16

Liver disease;
Active peptic ulcer disease;
Recent myocardial infarction;
Hypotension;
Internal malignancy within past 5 years;
Renal impairment with eGFR\<15 mL/min/1.73 m2;
Being unable for follow up due to social reasons;
Gorlin's syndrome or other genetic skin cancer syndrome;
Huge number of current skin cancers;
Metastatic SCC or invasive melanoma within the past 5 years;
Pregnancy or lactation;
Need for ongoing carbamazepine use (which could have a possible interaction with NAM);
Use of acitretin or other oral retinoids within the past 6 months;
Use of supplemental NAM, niacin, vitamin A, or beta carotene within the past 6 months;
Field treatment for actinic keratoses (AKs) within the previous 4 weeks;
Use of topical steroids.