Vitamin A Status in Patients With Vocal Fold Leukoplakia

Running, not enrolling

Conditions studied: Vitamin A, Vitamin A Deficiency, Leukoplakia, Vocal Cord Neoplasm

In brief

This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.

Key facts

Study ID

NCT05323292

Run by

University of Wisconsin, Madison

People needed

50

Starts

2022-06-29

Expected to finish

2026-12-31

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Wisconsin Hospitals and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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