Pilot Trial of Supplemental Vitamin A and Nicotinamide

NCT ID: NCT05702398

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-10-01

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.

Conditions

Skin Cancer; Kidney Transplant Recipients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin A & Nicotinamide

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

Group Type: EXPERIMENTAL

Vitamin A

Intervention Type: DRUG

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

Nicotinamide

Intervention Type: DRUG

500 mg NAM twice a day for 6 months

Placebo

Identical placebo pills twice a day

Group Type: PLACEBO_COMPARATOR

Other: Placebo

Intervention Type: OTHER

Identical placebo pills twice a day

Interventions

Vitamin A

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

Intervention Type: DRUG

Nicotinamide

500 mg NAM twice a day for 6 months

Intervention Type: DRUG

Other: Placebo

Identical placebo pills twice a day

Intervention Type: OTHER

Other Intervention Names

Niacin (Vitamin B3)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Eunyoung Cho, ScD

Role: CONTACT

Eunyoung_Cho@brown.edu

401-863-5895

Other Identifiers

19792

Identifier Type: -

Identifier Source: org_study_id