Status:
ENROLLING_BY_INVITATION
Vitamin A Status in Patients With Vocal Fold Leukoplakia
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Vitamin A
Vitamin A Deficiency
Eligibility:
All Genders
18+ years
Brief Summary
This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.
Detailed Description
The investigator's overarching goal is to determine if there is a pathophysiologic rationale for vitamin A supplementation in the treatment of vocal fold hyperkeratosis. Vocal fold hyperkeratosis is a...
Eligibility Criteria
Inclusion
- Willing to provide informed consent.
- Willing to comply with all study procedures and be available for the duration of the study.
- Ability to take oral medication.
- At least 18 years of age.
- Leukoplakia study groups:
- Leukoplakia due to hyperkeratosis with dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with dysplasia.
- Leukoplakia due to hyperkeratosis with no dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia.
- Control group: Laryngoscopy showing no evidence of vocal fold epithelial disease.
Exclusion
- History of malignant vocal fold epithelial pathology.
- History of metabolic or liver disorder.
- History of anorexia or bulimia.
- Pregnant, lactating, or planning on becoming pregnant during the study period.
- History of \>4.5 kg weight loss in the past 90 days.
- Medical or other inability to complete an 8 hour fast.
- Acute respiratory or gastrointestinal illness.
- Currently incarcerated.
- Impaired decision-making capacity.
- No or limited English speaking ability; illiterate or low-literacy ability.
- Profound visual or hearing impairment that limits written or verbal communication.
- Status relationship with a member of the study team.
- Not suitable for study participation due to other reasons at the discretion of the investigators.
Key Trial Info
Start Date :
June 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05323292
Start Date
June 29 2022
End Date
December 31 2026
Last Update
December 17 2025
Active Locations (1)
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1
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States, 53792