Lactoferrin for COVID-19-Induced Taste or Smell Abnormality

NCT05760079 | Withdrawn

• 1 other identifier: IRB00074029
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Common side effects of corona virus disease 2019 (COVID-19) include disruptions in taste and smell function, which may persist for prolonged periods of time following recovery and resolution of COVID-19 infection. These disruptions not only reduce the hedonic pleasure derived from eating, but may also be detrimental to quality of life and could pose additional health risks (malnutrition) among patients with chronic illness or those enduring long-term complications from their previous COVID-19 infection. Previous studies conducted among patients with cancer experiencing taste and smell abnormalities have indicated improvement in taste and smell function following daily lactoferrin supplementation. Lactoferrin is a natural transferrin protein that scavenges and chelates iron byproducts produced as a function of lipid oxidation in the oral cavity following inflammation, infection, or toxicity of chemosensory tissues. The purpose of this pilot investigation is to assess the feasibility and preliminary effectiveness of lactoferrin supplementation (750mg per day for 30 days) for the treatment of taste and smell disturbances following COVID-19 infection. Approximately 40 patients who experienced disruptions in taste and smell following infection with COVID-19 will be recruited. Participants will complete baseline assessments (questionnaires, blood draw) and will be given 90 lactoferrin tablets (provided by Jarrow Formulas) in order to take 3 tablets per day for 30 days.

Conditions

Covid19; Taste Disorder, Secondary; Taste Disorders; Dysgeusia; Smell Disorder; Ageusia; Anosmia

Keywords

Lactoferrin; Taste disorder; Smell disorder; COVID-19

Outcome Measures

Primary Outcomes (3)

• Change in Taste disruption Scores

  Ageusia or dysgeusia determined by subjective Smell and Taste Questionnaire (TSQ). As part of the questionnaire, participants will be asked to rate their individual taste and smell abnormalities as "insignificant," "mild," "moderate," "severe," or "incapacitating." The tool yields a taste complaint score (0-10) on the basis of subject responses to nine questions addressing changes to the sense of taste. One point is added for each reported taste complaint and two points for a rating of "severe" or "incapacitating" on the severity of the taste abnormality question.

  Baseline to day 60

• Change in Smell disruption Scores

  Anosmia or Dysnosmia determined by subjective Smell and Taste Questionnaire (TSQ). As part of the questionnaire, participants will be asked to rate their individual taste and smell abnormalities as "insignificant," "mild," "moderate," "severe," or "incapacitating." The tool yields a taste complaint score (0-6) on the basis of subject responses to five questions addressing changes to the sense smell. A smell complaint score (0-6) will be generated by adding one point for a positive response to each of five questions addressing self-perceived changes to the sense of smell. Two points will be assigned to a severity rating of "severe" or "incapacitating" for the severity of the smell abnormality question.

  Baseline to day 60

• Change in Brief Smell Identification Test (B-SIT) Scores

  The B-SIT is a shorter 12-item version of the full 40-item University of Pennsylvania Smell Identification Test (UPSIT). It is a validated 5 minute screening test for detecting smell loss. The test employs 12 well known cross cultural odors in a scratch and sniff format. Percentile norms are based upon nearly 4000 subjects via the B-SIT administration manual and both the test and the manual with a scoring key are available from Sensonics, Inc. (sensonics.com/smell-products/brief-smell-identification-test.html).

  Baseline to day 60

Secondary Outcomes (3)

• Adult Eating Behavior Questionnaire (AEBQ)

  Baseline, day 30, day 60

• Functional Assessment of Anorexia/Cachexia Tool (FAACT)

  Baseline, day 30, day 60

• Euro Quality of Life (EuroQOL)

  Baseline, day 30, day 60

Other Outcomes (1)

• Daily self-monitoring

  daily for 60 days

Study Arms (1)

Lactoferrin Supplementation

EXPERIMENTAL

750mg lactoferrin (three 250mg tablets) per day for 30 days

Dietary Supplement: Lactoferrin

Interventions

Lactoferrin DIETARY_SUPPLEMENT

750mg of Jarrow formulas taken three times daily for 30 days

Also known as: Jarrow Formulas Apolactoferrin

Lactoferrin Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult aged 18 or older; diagnosis of COVID-19 in the past 6 months; self-reported disruption in taste and smell beginning after infection with COVID-19

You may not qualify if:

• remains infectious from Covid-19; pregnant or lactating; taste or smell disruption existed prior to covid-19 infection; has cancer or is receiving cancer therapy; milk and/or iron allergy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

COVID-19; Taste Disorders; Dysgeusia; Olfaction Disorders; Ageusia; Anosmia

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Glenn J Lesser, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 8, 2023
• Study Start: June 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 8, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share