Vitamin ANCT05323292
Vitamin A Status in Patients With Vocal Fold Leukoplakia
An observational study of Vitamin A and Vitamin A Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin A, Vitamin A Deficiency, Leukoplakia
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
About this study
This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.
Read the 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
- Medical subject headings
- Vitamin A Deficiency, Leukoplakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A liver reserves
Total vitamin A liver concentration determined using retinol stable isotope dilution (μmol/g)
Measured: 14 days
Secondary outcomes (3)
Serum retinol
Serum retinol concentration (μmol/L)
Measured: Baseline
Serum retinyl esters
Serum retinyl esters concentration (μmol/L)
Measured: Baseline
Serum carotenoids
Serum carotenoid concentrations (μmol/L)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start29 Jun 2022
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin AStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Nathan Welham, PhD, CCC-SLP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323292
- Sponsor's protocol ID
- 2021-1045
- Other IDs
- R01DC019357, A539770, 07/2024, SMPH/SURGERY/SURGERY*OT, 2021-1045
- Status last verified
- Jul 2026
- First submitted
- 15 Mar 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Status in Patients With Vocal Fold Leukoplakia
- ClinicalTrials.gov ID
- NCT05323292
- Acronym / sponsor ID
- 2021-1045
- Conditions
- Vitamin A, Vitamin A Deficiency, Leukoplakia, Vocal Cord Neoplasm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin A liver reserves
Time frame: 14 days
Total vitamin A liver concentration determined using retinol stable isotope dilution (μmol/g)
3 secondary outcomes
Serum retinol
Time frame: Baseline
Serum retinyl esters
Time frame: Baseline
Serum carotenoids
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Welham, PhD, CCC-SLP principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin A and Vitamin A Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin A liver reserves (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.