Pilot Trial of Supplemental Vitamin A and Nicotinamide
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhode Island Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Liver disease;
Active peptic ulcer disease;
Recent myocardial infarction;
Hypotension;
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin A
Drug1,000 μg retinyl palmitate twice a day for 6 months
Nicotinamide
Drug500 mg NAM twice a day for 6 months
Other: Placebo
Other interventionIdentical placebo pills twice a day
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Vitamin A & NicotinamideExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of Blood Vitamin A and Nicotinamide Levels
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov