Vitamin A Status in Patients With Vocal Fold Leukoplakia

NCT05323292 | Enrolling By Invitation

• 5 other identifiers: 2021-1045R01DC019357A53977007/01/2021SMPH/SURGERY/SURGERY*OT
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin A; Vitamin A Deficiency; Leukoplakia; Vocal Cord Neoplasm

Outcome Measures

Primary Outcomes (1)

• Vitamin A liver reserves

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

  14 days

Secondary Outcomes (3)

• Serum retinol

  Baseline

• Serum retinyl esters

  Baseline

• Serum carotenoids

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified from the active caseloads of speech-language pathologists or otolaryngologists. During a routine clinical encounter, a member of the clinical team will inform potential participants of the research opportunity.

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.

Sponsors & Collaborators

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

Study Sites (1)

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Vitamin A Deficiency; Leukoplakia

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Precancerous Conditions; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan Welham, PhD, CCC-SLP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 12, 2022
• Study Start: June 29, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)