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Vitamin a levels under the microscope in voice box lesion study

NCT ID NCT05323292

Knowledge-focused Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study looks at vitamin A levels in 90 adults with vocal fold leukoplakia, a condition that causes white patches on the vocal cords. Researchers want to see if vitamin A status differs between people with and without precancerous changes. Participants provide blood and tissue samples, and take an oral vitamin A tracer. This is an observational study, not a treatment trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

50 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

glottis neoplasm laryngeal neoplasm leukoplakia vitamin A deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukoplakia Vitamin A Vitamin A deficiency Vocal cord neoplasm

Contacts and locations

Locations

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792, United States

More trials for these conditions

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