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Recruiting NCT05702398

Pilot Trial of Supplemental Vitamin A and Nicotinamide

Early Phase I Interventional Skin Cancer Kidney Transplant Recipients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin A, Nicotinamide, Other: Placebo.
Who it may be relevant to
Registry conditions: Skin Cancer, Kidney Transplant Recipients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide

Overview

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.

Interventions

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

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Rhode Island Hospital — Providence

Identifiers

NCT: NCT05702398 · 19792

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗