Pilot Trial of Supplemental Vitamin A and Nicotinamide

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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05702398

Enrollment

Registered

2023-01-27

Start date

2023-04-01

Completion date

2028-03-01

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients, Skin Cancer

Brief 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.

Interventions

DRUGVitamin A

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

DRUGNicotinamide

500 mg NAM twice a day for 6 months

OTHEROther: Placebo

Identical placebo pills twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change of Blood Vitamin A and Nicotinamide Levels	6 months

Countries

United States

Contacts

CONTACTEunyoung Cho, ScD

Eunyoung_Cho@brown.edu401-863-5895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026