Taste And Smell TEsting in End Stage Renal Disease

NCT ID: NCT03043144

Last Updated: 2017-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-15

Study Completion Date

2017-04-01

Brief Summary

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Malnutrition is an important complication of advanced kidney disease and impairment in smell and taste may affect nutritional status. This study will examine the association between impairment in smell and taste and nutritional and functional markers among patients with end stage renal disease, as well as risk factors for smell and taste impairment.

Detailed Description

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People with advanced chronic kidney disease (CKD) are at risk for malnutrition, which is associated with significantly increased mortality. Impairments in olfaction and taste are under-recognized and under-addressed symptoms that affect this population. Olfaction and taste influence appetite and nutritional status and represent a unique target for study and intervention. Small cross-sectional studies have shown a higher prevalence of olfactory (up to 56%) and taste disturbances (up to 35%) among patients with CKD compared with the general population, but little is known about longitudinal change in olfaction and taste in this population. Additionally, there is a lack of understanding about why these sensory disturbances more commonly occur in people with CKD, although there is speculation that uremia may contribute.

This information gained from this study will address these gaps in knowledge by studying longitudinal changes in olfaction and taste and their associations with concurrent and future nutritional and functional status. Additionally this study will attempt to identify potentially modifiable risk factors associated with olfactory and taste impairment.

Conditions

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Kidney Failure, Chronic Olfaction Disorders Taste Disorders Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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End stage renal disease

Observational study, no intervention

Worsening of olfaction from enrollment visit to 6 months

Intervention Type OTHER

Worsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes

Worsening of taste from enrollment visit to 6 months

Intervention Type OTHER

Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes

Serum Zinc

Intervention Type OTHER

Serum zinc will be evaluated for association with taste and/or smell impairment

Chronic rhinosinusitis

Intervention Type OTHER

Chronic rhinosinusitis will be evaluated for association with smell impairment

Dialysis adequacy

Intervention Type OTHER

Dialysis adequacy will be evaluated for association with taste and/or smell impairment

Decayed missing filled teeth index (DMFT)

Intervention Type OTHER

DMFT will be evaluated for association with taste impairment

Interventions

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Worsening of olfaction from enrollment visit to 6 months

Worsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes

Intervention Type OTHER

Worsening of taste from enrollment visit to 6 months

Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes

Intervention Type OTHER

Serum Zinc

Serum zinc will be evaluated for association with taste and/or smell impairment

Intervention Type OTHER

Chronic rhinosinusitis

Chronic rhinosinusitis will be evaluated for association with smell impairment

Intervention Type OTHER

Dialysis adequacy

Dialysis adequacy will be evaluated for association with taste and/or smell impairment

Intervention Type OTHER

Decayed missing filled teeth index (DMFT)

DMFT will be evaluated for association with taste impairment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 18 or older
* End-stage renal disease requiring chronic dialysis

Exclusion Criteria

* Known allergy to quinine
* Presence of a pacemaker or internal defibrillator
* Pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Katherine Lynch

Instructor in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Lynch, MD, SM

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2016P000152

Identifier Type: -

Identifier Source: org_study_id

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