Vitamin A Status in Patients With Vocal Fold Leukoplakia

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05323292
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
90
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54.1
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Vitamin A Status in Patients With Vocal Fold Leukoplakia
    Actual Study Start Date :
    Jun 29, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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 mucosal disease.

    Outcome Measures

    Primary Outcome Measures

    1. Vitamin A liver reserves [14 days]

      Total vitamin A liver concentration determined using retinol stable isotope dilution (μmol/g)

    Secondary Outcome Measures

    1. Serum retinol [Baseline]

      Serum retinol concentration (μmol/L)

    2. Serum retinyl esters [Baseline]

      Serum retinyl esters concentration (μmol/L)

    3. Serum carotenoids [Baseline]

      Serum carotenoid concentrations (μmol/L)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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:

    6. Leukoplakia due to hyperkeratosis with dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with dysplasia.

    7. Leukoplakia due to hyperkeratosis with no dysplasia: biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia.

    8. Control group: Laryngoscopy showing no evidence of vocal fold mucosal disease.

    Exclusion Criteria:
    1. History of malignant vocal fold mucosal 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Hospitals and Clinics Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • University of Wisconsin, Madison
    • National Institute on Deafness and Other Communication Disorders (NIDCD)

    Investigators

    • Principal Investigator: Nathan Welham, PhD, CCC-SLP, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT05323292
    Other Study ID Numbers:
    • 2021-1045
    • R01DC019357
    • A539770
    • 07/01/2021
    • SMPH/SURGERY/SURGERY*OT
    • 2021-1045
    First Posted:
    Apr 12, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 19, 2022