Pilot Trial of Supplemental Vitamin A and Nicotinamide

Early Phase 1

Not yet recruiting

• Conditions: Skin Cancer; Kidney Transplant Recipients
• Interventions: Drug: Vitamin A; Drug: Nicotinamide

• Registration Number: NCT05702398
• Lead Sponsor: Rhode Island Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Last Update Submitted: 2023-01-18
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27
• Study Start: 2023-03-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A & Nicotinamide	Vitamin A	1,000 μg retinyl palmitate and 500 mg NAM twice a day
Vitamin A & Nicotinamide	Nicotinamide	1,000 μg retinyl palmitate and 500 mg NAM twice a day

Primary Outcome Measures

Name	Time	Method
Change of Blood Vitamin A and Nicotinamide Levels	6 months