Pilot Trial of Supplemental Vitamin A and Nicotinamide

• Sponsor: Rhode Island Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05702398
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Cancer; Kidney Transplant Recipients	Drug: Vitamin A; Drug: Nicotinamide; Other: Other: Placebo	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin A & Nicotinamide 1,000 μg retinyl palmitate and 500 mg NAM twice a day	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 Names: Niacin (Vitamin B3)
Placebo Comparator: Placebo Identical placebo pills twice a day	Other: Other: Placebo; Identical placebo pills twice a day

Outcome Measures

Primary Outcome Measures

1. Change of Blood Vitamin A and Nicotinamide Levels [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rhode Island Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rhode Island Hospital
• ClinicalTrials.gov Identifier: NCT05702398
• Other Study ID Numbers: 19792
• First Posted: Jan 27, 2023
• Last Update Posted: Jan 27, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Neoplasms; Vitamins; Vitamin A; Niacin; Niacinamide; Nicotinic Acids

Study Results

No Results Posted as of Jan 27, 2023