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Pilot Trial of Supplemental Vitamin A and Nicotinamide

RecruitingEARLY Phase 1Ages 18 Years - anyAllRhode Island Hospital
NCT05702398 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vitamin A
  • Nicotinamide
  • Other: Placebo
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Where

1 site
Rhode Island Hospital
Providence, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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