Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
Rhode Island Hospital
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * 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 unab…
Interventions
- DrugVitamin A
1,000 μg retinyl palmitate twice a day for 6 months
- DrugNicotinamide
500 mg NAM twice a day for 6 months
- OtherOther: Placebo
Identical placebo pills twice a day
Location
- Rhode Island HospitalProvidence, Rhode Island