Pilot Trial of Supplemental Vitamin A and Nicotinamide

Lifespan

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Kidney Transplant Recipients; Skin Cancer

Treatments: Drug: Nicotinamide; Other: Other: Placebo; Drug: Vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT05702398

19792

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups, including a placebo group

Vitamin A & Nicotinamide

Experimental group

Description:

1,000 μg retinyl palmitate and 500 mg NAM twice a day

Treatment:

Drug: Vitamin A

Drug: Nicotinamide

Placebo

Placebo Comparator group

Description:

Identical placebo pills twice a day

Treatment:

Other: Other: Placebo