Actively Recruiting
Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
Led by Rhode Island Hospital · Updated on 2026-03-20
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and feasibility of taking oral nicotinamide, a form of vitamin B3, together with vitamin A in people who have received a kidney transplant and have a history of skin cancer. This early-phase clinical trial aims to gather preliminary data that may support future studies focused on preventing cancer in this high-risk group. Participants will be randomly assigned to one of two groups: one group will receive vitamin A (1,000 micrograms retinyl palmitate) and nicotinamide (500 mg) twice daily, while the other group will take identical placebo pills twice daily. The treatment period lasts for six months, during which participants will take the assigned pills regularly. Throughout the study, researchers will monitor changes in blood levels of vitamin A and nicotinamide at six months. Participants will be assessed for safety and treatment adherence. This trial includes follow-up visits and evaluations to track these changes and ensure participant safety over the course of the study.
CONDITIONS
Brief Title
Pilot Trial of Supplemental Vitamin A and Nicotinamide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or greater
- History of 2 or more confirmed invasive cutaneous squamous cell carcinomas in the past 2 years or at least one treatment for 15 or more benign or premalignant skin lesions
- Able to understand, read, and write English proficiently
You will not qualify if you...
- Liver disease
- Active peptic ulcer disease
- Recent myocardial infarction
- Hypotension
- Internal malignancy within past 5 years
- Renal impairment with eGFR less than 15 mL/min/1.73 m2
- Unable to follow up due to social reasons
- Genetic skin cancer syndromes such as Gorlin's syndrome
- Extensive current skin cancers
- Metastatic squamous cell carcinoma or invasive melanoma within past 5 years
- Pregnancy or breastfeeding
- Need for ongoing carbamazepine use
- Use of acitretin or other oral retinoids within past 6 months
- Use of supplemental nicotinamide, niacin, vitamin A, or beta carotene within past 6 months
- Field treatment for actinic keratoses within past 4 weeks
- Use of topical steroids on the skin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take either Vitamin A and Nicotinamide or placebo pills twice a day as part of the study intervention.
Monthly visits for up to 6 months
Trial Site Locations
Total: 1 location
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02912
Actively Recruiting
Research Team
E
Eunyoung Cho, ScD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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