Clinical trial · Interventional
Pilot Trial of Supplemental Vitamin A and Nicotinamide
Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
NCT05702398CI-TRIAL-00106140recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Transplant Recipients | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nicotinamide | Drug | Niacinamide | ALIAS |
| Other: Placebo | Other | — | UNRESOLVED |
| Vitamin A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin A & Nicotinamide
- description
- 1,000 μg retinyl palmitate and 500 mg NAM twice a day
- interventionNames
- Drug: Vitamin A
- Drug: Nicotinamide
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Identical placebo pills twice a day
- interventionNames
- Other: Other: Placebo
Primary outcomes (1)
- measure
- Change of Blood Vitamin A and Nicotinamide Levels
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.