Pilot Trial of Supplemental Vitamin A and Nicotinamide

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05702398
• Other study ID #: 19792
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 1, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2022
• Source: Rhode Island Hospital
• Contact: Eunyoung Cho, ScD
• Phone: 401-863-5895
• Email: Eunyoung_Cho[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Recipients
• Skin Cancer
• Skin Neoplasms

Intervention

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

Other:
• Other: Placebo
Identical placebo pills twice a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Blood Vitamin A and Nicotinamide Levels		6 months