By InvitationNot Applicable

Vitamin A Status in Patients With Vocal Fold Leukoplakia

United States90 participantsStarted 2022-06-29

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Vitamin A liver reserves

Timeframe: 14 days

Trial details

NCT IDNCT05323292

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Vitamin A trials