Pilot Trial of Supplemental Vitamin A and Nicotinamide

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT05702398
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vitamin A — DRUG
    1,000 μg retinyl palmitate twice a day for 6 months
  • Nicotinamide — DRUG
    500 mg NAM twice a day for 6 months
  • Other: Placebo — OTHER
    Identical placebo pills twice a day

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Mar 2026
Primary completion
Jan 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Vitamin A & Nicotinamide
    1,000 μg retinyl palmitate and 500 mg NAM twice a day
  • Placebo Comparator: Placebo
    Identical placebo pills twice a day

Primary Outcome Measure

Change of Blood Vitamin A and Nicotinamide Levels [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02912
Eunyoung Cho
401-863-5895

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