Clinical trial NCT03043144: Taste And Smell TEsting in End Stage Renal Disease
Official title: TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Kidney Failure, Chronic
Olfaction Disorders
Taste Disorders
Malnutrition
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in lean body mass
timeFrame: from 6 months to 1 year
Secondary outcomes:
measure: change in hand grip strength
timeFrame: from 6 months to 1 year
measure: change in the physical function score
timeFrame: from 6 months to 1 year
Other outcomes:
measure: change in serum albumin
timeFrame: from 6 months to 1 year
measure: change in dietary intake
timeFrame: from 6 months to 1 year
measure: change in anthropometric measures
timeFrame: from 6 months to 1 year
measure: change in serum cholesterol
timeFrame: from 6 months to 1 year
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Katherine Lynch, MD, SM
role: PRINCIPAL_INVESTIGATOR
References: