TSA: Lactoferrin for COVID-19-Induced Taste or Smell Abnormality

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05760079

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Taste Disorder, Secondary Taste Disorders Dysgeusia Smell Disorder Ageusia Anosmia	Dietary Supplement: Lactoferrin	N/A

Detailed Description

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. Primary outcomes will be subjective change in taste and smell abnormalities obtained via the Taste and Smell Questionnaire (TSQ).

Approximately 40 patients who experienced disruptions in taste and smell following infection with COVID-19 will be recruited. Participants will complete baseline assessments. Participants will be given 90 lactoferrin tablets (provided by Jarrow Formulas) in order to take 3 tablets per day for 30 days. Primary outcomes will be assessed immediately following the 30 day supplementation period. After 30 additional days without lactoferrin supplements (a washout period), participants will complete follow-up assessments.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study of Lactoferrin Among Patients Reporting Taste or Smell Abnormalities After COVID-19

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactoferrin Supplementation 750mg lactoferrin (three 250mg tablets) per day for 30 days	Dietary Supplement: Lactoferrin 750mg of Jarrow formulas taken three times daily for 30 days Other Names: Jarrow Formulas Apolactoferrin

Arm

Intervention/Treatment

Experimental: Lactoferrin Supplementation

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

Dietary Supplement: Lactoferrin

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

Other Names:

Jarrow Formulas Apolactoferrin

Outcome Measures

Primary Outcome Measures

Change in Taste disruption Scores [Baseline to day 60]
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.
Change in Smell disruption Scores [Baseline to day 60]
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.
Change in Brief Smell Identification Test (B-SIT) Scores [Baseline to day 60]
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).

Secondary Outcome Measures

Adult Eating Behavior Questionnaire (AEBQ) [Baseline, day 30, day 60]
Patient reported outcome of quality of life related to change in chemosensory function A validated, 35-item self-report measure that provides a comprehensive, convenient, and easy-to-use measure of an adult's appetite across 8 appetitive traits: Hunger (H), Food Responsiveness (FR), Emotional Over-Eating (EOE), Enjoyment of Food (EF), Satiety Responsiveness (SR), Emotional Under-eating (EUE), Food Fussiness (FF) and Slowness in Eating (SE). The AEBQ appears to be a reliable measure of appetitive traits in adults which translates well from the validated child measure (Child Eating Behaviour Questionnaire), and is unique in that it's scales assess food approach as well as food avoidance.95 Food Approach appetitive traits relevant to "Enjoyment of Food" will be assessed with 3 questions: "I enjoy eating", "I love food", and "I look forward to mealtimes". Internal reliability of the "Enjoyment of Food" subscale is 0.859 (Chronbach's alpha).
Functional Assessment of Anorexia/Cachexia Tool (FAACT) [Baseline, day 30, day 60]
Patient reported outcome of factors related to anorexia and cachexia. Functional Assessment of Anorexia/Cachexia Treatment tool contains a validated 12 question additional concerns module, in addition to the Functional Assessment of Cancer Therapy - General (FACT-G), which measures nutritional quality of life.
Euro Quality of Life (EuroQOL) [Baseline, day 30, day 60]
The EuroQOL is a self-reported generic health-related QoL (HRQoL) instrument that specifically addresses health status and has been tested among individuals with COVID-19 with taste and smell abnormality.4 It consists of five questions on mobility, self-care, usual activities, pain and discomfort and anxiety and depression with 3-point response categories (1=no problems, 2=some problems and 3=serious or extreme problems). The EQ-visual analogue scale (VAS) component of EQ-5D asks respondents to rate their overall health status from 0 (worst imaginable health) to 100 (best imaginable health).

Other Outcome Measures

Daily self-monitoring [daily for 60 days]
Participants will track their taste and smell function each day as well as their use of the lactoferrin supplement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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