NCT05702398 · Rhode Island Hospital
Pilot Trial of Supplemental Vitamin A and Nicotinamide
What this study is about
The goal of this clinical trial is to assess the feasibility and safety of taken by mouth 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.
View original scientific description
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.
Interventions
DRUG
Vitamin A
1,000 μg retinyl palmitate twice a day for 6 months
DRUG
Nicotinamide
500 mg NAM twice a day for 6 months
OTHER
Other: Placebo
Identical placebo pills twice a day
Primary outcome measures
Change of Blood Vitamin A and Nicotinamide Levels
Time frame: 6 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations