NCT05323292

Vitamin A Status in Patients With Vocal Fold Leukoplakia

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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 an accumulation of epithelial surface keratin resulting in clinical leukoplakia. It is primarily managed using destructive techniques that risk iatrogenic injury, fibrosis, and voice impairment. Given the potential morbidity of biopsy and lesion removal, there is a need for new approaches to the prevention and treatment of vocal fold leukoplakic disorders that are non-destructive. Vitamin A is a key regulator of epithelial health and systemic vitamin A deficiency could directly contribute to hyperkeratosis. Based on vitamin A's importance to vocal fold stellate and epithelial cell biology and its direct relevance to vocal fold hyperkeratosis, this study will assess vitamin A status in participants with vocal fold hyperkeratosis. An association would suggest further study on the effects of vitamin A optimization and/or supplementation in patients with leukoplakia, as well as an adjuvant therapy in participants for whom surgical treatment is indicated.

Conditions

• Vitamin A
• Vitamin A Deficiency
• Leukoplakia
• Vocal Cord Neoplasm

Timeline

• Start date: 2022-06-29
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2022-04-12
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States