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Pilot Trial of Supplemental Vitamin A and Nicotinamide

Primary Purpose

Skin Cancer, Kidney Transplant Recipients

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Vitamin A
Nicotinamide
Other: Placebo
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin A & Nicotinamide

    Placebo

    Arm Description

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

    Identical placebo pills twice a day

    Outcomes

    Primary Outcome Measures

    Change of Blood Vitamin A and Nicotinamide Levels

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2023
    Last Updated
    January 18, 2023
    Sponsor
    Rhode Island Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05702398
    Brief Title
    Pilot Trial of Supplemental Vitamin A and Nicotinamide
    Official Title
    Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rhode Island Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Cancer, Kidney Transplant Recipients

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin A & Nicotinamide
    Arm Type
    Experimental
    Arm Description
    1,000 μg retinyl palmitate and 500 mg NAM twice a day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Identical placebo pills twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin A
    Intervention Description
    1,000 μg retinyl palmitate twice a day for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Nicotinamide
    Other Intervention Name(s)
    Niacin (Vitamin B3)
    Intervention Description
    500 mg NAM twice a day for 6 months
    Intervention Type
    Other
    Intervention Name(s)
    Other: Placebo
    Intervention Description
    Identical placebo pills twice a day
    Primary Outcome Measure Information:
    Title
    Change of Blood Vitamin A and Nicotinamide Levels
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eunyoung Cho, ScD
    Phone
    401-863-5895
    Email
    Eunyoung_Cho@brown.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Pilot Trial of Supplemental Vitamin A and Nicotinamide

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