NCT05702398RecruitingEarly Phase 1
Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Rhode Island Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change of Blood Vitamin A and Nicotinamide Levels
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vitamin A & Nicotinamide
Experimental
1,000 μg retinyl palmitate and 500 mg NAM twice a day
Intervention: Vitamin A (Drug)
Vitamin A & Nicotinamide
Experimental
1,000 μg retinyl palmitate and 500 mg NAM twice a day
Intervention: Nicotinamide (Drug)
Outcomes
Primary Outcomes
Change of Blood Vitamin A and Nicotinamide Levels
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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