Taste And Smell TEsting in End Stage Renal Disease

Withdrawn

• Conditions: Kidney Failure, Chronic; Olfaction Disorders; Taste Disorders; Malnutrition
• Interventions: Other: Worsening of olfaction from enrollment visit to 6 months; Other: Worsening of taste from enrollment visit to 6 months; Other: Serum Zinc; Other: Chronic rhinosinusitis; Other: Dialysis adequacy; Other: Decayed missing filled teeth index (DMFT)

• Registration Number: NCT03043144
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2017-02-15
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
End stage renal disease	Worsening of olfaction from enrollment visit to 6 months	Observational study, no intervention
End stage renal disease	Worsening of taste from enrollment visit to 6 months	Observational study, no intervention
End stage renal disease	Serum Zinc	Observational study, no intervention
End stage renal disease	Decayed missing filled teeth index (DMFT)	Observational study, no intervention
End stage renal disease	Dialysis adequacy	Observational study, no intervention
End stage renal disease	Chronic rhinosinusitis	Observational study, no intervention

Primary Outcome Measures

Name	Time	Method
change in lean body mass	from 6 months to 1 year	lean body mass will be determined by dual-energy X-ray absorptiometry scan

Secondary Outcome Measures

Name	Time	Method
change in hand grip strength	from 6 months to 1 year	measured by dynamometer
change in the physical function score	from 6 months to 1 year	measured by Standard-Form 36 version 2

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States