Recruiting
Early Phase 1

Nicotinamide & Vitamin A

Sponsor:

Rhode Island Hospital

Code:

NCT05702398

Conditions

Skin Cancer

Kidney Transplant Recipients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin A

Nicotinamide

Other: Placebo

Study Details

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

Study ID

NCT05702398

Start date

Apr 1, 2023

Status verified date

Mar, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vitamin A & Nicotinamide

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

placebo comparator: Placebo

Identical placebo pills twice a day

Interventions

Vitamin A

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

Nicotinamide

500 mg NAM twice a day for 6 months

Other: Placebo

Identical placebo pills twice a day

Primary outcome measure

  • Change of Blood Vitamin A and Nicotinamide Levels [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Eunyoung Cho, ScD

401-863-5895Eunyoung_Cho@brown.edu

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Eunyoung Cho

401-863-5895Eunyoung_Cho@brown.edu

More Information

Sponsor

Rhode Island Hospital

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-03-20.