Taste And Smell TEsting in End Stage Renal Disease

Malnutrition Clinical Trial

— TASTE ESRD  

Official title:

TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03043144
• Other study ID #: 2016P000152
• Status: Withdrawn
• Phase: N/A
• First received: February 2, 2017
• Last updated: June 22, 2017
• Start date: February 15, 2017
• Est. completion date: April 1, 2017

Study information

• Verified date: June 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Malnutrition
• Olfaction Disorders
• Renal Insufficiency
• Taste Disorders

Intervention

Other:
• 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
• 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
• Serum Zinc
Serum zinc will be evaluated for association with taste and/or smell impairment
• Chronic rhinosinusitis
Chronic rhinosinusitis will be evaluated for association with smell impairment
• Dialysis adequacy
Dialysis adequacy will be evaluated for association with taste and/or smell impairment
• Decayed missing filled teeth index (DMFT)
DMFT will be evaluated for association with taste impairment

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in serum albumin	change in serum albumin	from 6 months to 1 year
Other	change in dietary intake	measured by a food frequency questionnaire	from 6 months to 1 year
Other	change in anthropometric measures	triceps skinfold thickness, mid arm circumference, and weight	from 6 months to 1 year
Other	change in serum cholesterol	change in serum cholesterol	from 6 months to 1 year
Primary	change in lean body mass	lean body mass will be determined by dual-energy X-ray absorptiometry scan	from 6 months to 1 year
Secondary	change in hand grip strength	measured by dynamometer	from 6 months to 1 year
Secondary	change in the physical function score	measured by Standard-Form 36 version 2	from 6 months to 1 year