Pilot Trial of Supplemental Vitamin A and Nicotinamide
Recruiting now · Early Phase 1 · Has a placebo group
Conditions studied: Skin Cancer, Kidney Transplant Recipients
In brief
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.
Key facts
- Study ID
- NCT05702398
- Run by
- Rhode Island Hospital
- People needed
- 30
- Starts
- 2023-04-01
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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;
- Use of topical steroids.
Where it is running
- Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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