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NCT Number: NCT05702398

Pilot Trial of Supplemental 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02912, United States

Location status: Recruiting

Location contact

Eunyoung Cho

CONTACT

[email protected]

401-863-5895

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin A

Drug

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

Nicotinamide

Drug

500 mg NAM twice a day for 6 months

Other names: Niacin (Vitamin B3)

Other: Placebo

Other

Identical placebo pills twice a day

Primary outcomes

  1. Change of Blood Vitamin A and Nicotinamide Levels

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Eunyoung Cho, ScD

CONTACT

[email protected]

401-863-5895

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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