Pilot Trial of Supplemental Vitamin A and Nicotinamide

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer; Kidney Transplant Recipients
• Intervention / Treatment: Drug: Vitamin A; Drug: Nicotinamide; Other: Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Eunyoung Cho, ScD; Phone Number: 401-863-5895; Email: Eunyoung_Cho@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Rhode Island Hospital
      • Contact: Eunyoung Cho; Phone Number: 401-863-5895; Email: Eunyoung_Cho@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin A & Nicotinamide; 1,000 μg retinyl palmitate and 500 mg NAM twice a day	Drug: Vitamin A; 1,000 μg retinyl palmitate twice a day for 6 months; Drug: Nicotinamide; 500 mg NAM twice a day for 6 months; Other Names: Niacin (Vitamin B3)
Placebo Comparator: Placebo; Identical placebo pills twice a day	Other: Other: Placebo; Identical placebo pills twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of Blood Vitamin A and Nicotinamide Levels	6 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Neoplasms; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Diterpenes; Acids, Heterocyclic; Nicotinic Acids; Vitamin A; Niacin; Niacinamide
• Other Study ID Numbers: 19792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No