Skin CancerEarly Phase 1NCT05702398
Pilot Trial of Supplemental Vitamin A and Nicotinamide
A Early Phase 1 study testing Vitamin A and Nicotinamide in people with Skin Cancer and Kidney Transplant Recipients, run by Rhode Island Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Kidney Transplant Recipients
- What is being tested?
- Vitamin A and Nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02912
Eunyoung Cho, 401-863-5895, Eunyoung_Cho@brown.edu
About this study
Official title: Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
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
- Being tested
- Vitamin A, Nicotinamide, Other: Placebo
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
1,000 μg retinyl palmitate twice a day for 6 months
NicotinamideDrug
Also called Niacin (Vitamin B3)
500 mg NAM twice a day for 6 months
Other: PlaceboOther
Identical placebo pills twice a day
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A & Nicotinamide | Experimental | 1,000 μg retinyl palmitate and 500 mg NAM twice a day Receives: Drug: Vitamin A; Drug: Nicotinamide |
| Placebo | Placebo comparator | Identical placebo pills twice a day Receives: Other: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Blood Vitamin A and Nicotinamide Levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Apr 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702398
- Sponsor's protocol ID
- 19792
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
- ClinicalTrials.gov ID
- NCT05702398
- Acronym / sponsor ID
- 19792
- Conditions
- Skin Cancer, Kidney Transplant Recipients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin A & Nicotinamide | Experimental | Drug: Vitamin A, Drug: Nicotinamide1,000 μg retinyl palmitate and 500 mg NAM twice a day |
| Placebo | Placebo comparator | Other: Other: PlaceboIdentical placebo pills twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- Liver disease;
- Active peptic ulcer disease;
- Recent myocardial infarction;
- Hypotension;
- Internal malignancy within past 5 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A1,000 μg retinyl palmitate twice a day for 6 months | Drug | Vitamin A & Nicotinamide |
| NicotinamideAlso: Niacin (Vitamin B3)500 mg NAM twice a day for 6 months | Drug | Vitamin A & Nicotinamide |
| Other: PlaceboIdentical placebo pills twice a day | Other | Placebo |
Primary outcome
Change of Blood Vitamin A and Nicotinamide Levels
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin A and Nicotinamide in people with Skin Cancer and Kidney Transplant Recipients, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunyoung Cho, ScD (401-863-5895, Eunyoung_Cho@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Blood Vitamin A and Nicotinamide Levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.