Pilot Trial of Supplemental Vitamin A and Nicotinamide

NCT05702398 | Recruiting Early Phase 1

• 1 other identifier: 19792
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Cancer; Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• Change of Blood Vitamin A and Nicotinamide Levels

  6 months

Study Arms (2)

Vitamin A & Nicotinamide

EXPERIMENTAL

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

Drug: Vitamin A; Drug: Nicotinamide

Placebo

PLACEBO COMPARATOR

Identical placebo pills twice a day

Other: Other: Placebo

Interventions

Vitamin A DRUG

1,000 μg retinyl palmitate twice a day for 6 months

Vitamin A & Nicotinamide

Nicotinamide DRUG

500 mg NAM twice a day for 6 months

Also known as: Niacin (Vitamin B3)

Vitamin A & Nicotinamide

Other: Placebo OTHER

Identical placebo pills twice a day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Vitamin A; Niacinamide; Niacin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Eunyoung Cho, ScD

CONTACT

401-863-5895; Eunyoung_Cho@brown.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)