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Lactoferrin for COVID-19-Induced Taste or Smell Abnormality (TSA)

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Withdrawn

Conditions

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

Treatments

Dietary Supplement: Lactoferrin

Study type

Interventional

Funder types

Other

Identifiers

NCT05760079
IRB00074029

Details and patient eligibility

About

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.

Full description

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. 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Lactoferrin Supplementation
Experimental group
Description:
750mg lactoferrin (three 250mg tablets) per day for 30 days
Treatment:
Dietary Supplement: Lactoferrin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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