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RECRUITINGEarly Phase 1INTERVENTIONAL

Pilot Trial of Supplemental Vitamin A and Nicotinamide

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 18 years old or greater; - Either History of 2 or more diagnosed by tissue sample (biopsy-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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (1)

Rhode Island Hospital
Providence, Rhode Island, United States