Clinical trial · Observational
Vitamin A Status in Patients With Vocal Fold Leukoplakia
NCT05323292CI-TRIAL-00118405active not recruitingClinicalTrials.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)
This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukoplakia | — | UNRESOLVED | — |
| Vitamin A | — | UNRESOLVED | — |
| Vitamin A Deficiency | — | UNRESOLVED | — |
| Vocal Cord Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Leukoplakia due to hyperkeratosis with dysplasia
- description
- Biopsy-confirmed diagnosis of hyperkeratosis with dysplasia
- label
- Leukoplakia due to hyperkeratosis with no dysplasia
- description
- Biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia
- label
- Control group
- description
- Laryngoscopy showing no evidence of vocal fold epithelial disease
Primary outcomes (1)
- measure
- Vitamin A liver reserves
- timeFrame
- 14 days
- description
- Total vitamin A liver concentration determined using retinol stable isotope dilution (μmol/g)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Willing to provide informed consent. 2. Willing to comply with all study procedures and be available for the duration of the study. 3. Ability to take oral medication. 4. At least 18 years of age. 5. Leukoplakia study groups: 1. Leukoplakia due to hyperkeratosis with dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with dysplasia. 2. Leukoplakia due to hyperkeratosis with no dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia. 6. Control group: Laryngoscopy showing no evidence of vocal fold epithelial disease. Exclusion Criteria: 1. History of malignant vocal fold epithelial pathology. 2. History of metabolic or liver disorder. 3. History of anorexia or bulimia. 4. Pregnant, lactating, or planning on becoming pregnant during the study period. 5. History of \>4.5 kg weight loss in the past 90 days. 6. Medical or other inability to complete an 8 hour fast. 7. Acute respiratory or gastrointestinal illness. 8. Currently incarcerated. 9. Impaired decision-making capacity. 10. No or limited English speaking ability; illiterate or low-literacy ability. 11. Profound visual or hearing impairment that limits written or verbal communication. 12. Status relationship with a member of the study team. 13. Not suitable for study participation due to other reasons at the discretion of the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.