Vitamin A Status in Patients With Vocal Fold Leukoplakia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-29

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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

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Vitamin A Vitamin A Deficiency Leukoplakia Vocal Cord Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Leukoplakia due to hyperkeratosis with dysplasia

Biopsy-confirmed diagnosis of hyperkeratosis with dysplasia.

No interventions assigned to this group

Leukoplakia due to hyperkeratosis with no dysplasia

Biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia.

No interventions assigned to this group

Control group

Laryngoscopy showing no evidence of vocal fold epithelial disease.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Welham, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States