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Trial Title:
Pilot Trial of Supplemental Vitamin A and Nicotinamide
NCT ID:
NCT05702398
Condition:
Skin Cancer
Kidney Transplant Recipients
Conditions: Official terms:
Skin Neoplasms
Vitamins
Vitamin A
Niacinamide
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Vitamin A
Description:
1,000 μg retinyl palmitate twice a day for 6 months
Arm group label:
Vitamin A & Nicotinamide
Intervention type:
Drug
Intervention name:
Nicotinamide
Description:
500 mg NAM twice a day for 6 months
Arm group label:
Vitamin A & Nicotinamide
Other name:
Niacin (Vitamin B3)
Intervention type:
Other
Intervention name:
Other: Placebo
Description:
Identical placebo pills twice a day
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2023
Completion date:
October 1, 2023
Lead sponsor:
Agency:
Rhode Island Hospital
Agency class:
Other
Source:
Rhode Island Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05702398
