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RecruitingNCT05702398Updated Mar 20, 2026

Pilot Trial of Supplemental Vitamin A and Nicotinamide

An Early Phase 1 interventional study of Vitamin A and Nicotinamide in Skin Cancer and Kidney Transplant Recipients, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Rhode Island Hospital · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Cancer
  • Kidney Transplant Recipients

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03

In context

Skin Neoplasms

582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.

This study's planned enrollment of 30 is below the median of 53 across 416 interventional studies indexed under Skin Neoplasms.

Browse Skin Neoplasms studies →

Lead sponsor

Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Vitamin A & Nicotinamide

    1,000 μg retinyl palmitate and 500 mg NAM twice a day

    Drug: Vitamin A · Drug: Nicotinamide

  • Placebo comparator
    Placebo

    Identical placebo pills twice a day

    Other: Other: Placebo

Interventions

  • DrugVitamin A

    1,000 μg retinyl palmitate twice a day for 6 months

  • DrugNicotinamide

    500 mg NAM twice a day for 6 months

    Also known as: Niacin (Vitamin B3)

  • OtherOther: Placebo

    Identical placebo pills twice a day

06

What researchers measure

Primary outcomes

  1. Change of Blood Vitamin A and Nicotinamide Levels

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Rhode Island Hospital
    Providence, Rhode Island 02912, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05702398
Lead sponsor
Rhode Island Hospital
Responsible party
Sponsor
First posted
Jan 27, 2023
Start date
Apr 1, 2023
Primary completion
Jan 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Mar 20, 2026

Study contacts

Eunyoung Cho, ScD
Contact
Eunyoung_Cho@brown.edu
401-863-5895

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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