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Trial record 2 of 71 for:    Taste Disorders | NIH

Taste And Smell TEsting in End Stage Renal Disease (TASTE ESRD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03043144
Recruitment Status : Withdrawn (Investigator leaving the institution)
First Posted : February 3, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Katherine Lynch, 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.

Condition or disease Intervention/treatment
Kidney Failure, Chronic Olfaction Disorders Taste Disorders Malnutrition 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)

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 Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
End stage renal disease
Observational study, no 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

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

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

Other: Chronic rhinosinusitis
Chronic rhinosinusitis will be evaluated for association with smell impairment

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

Other: Decayed missing filled teeth index (DMFT)
DMFT will be evaluated for association with taste impairment




Primary Outcome Measures :
  1. change in lean body mass [ Time Frame: from 6 months to 1 year ]
    lean body mass will be determined by dual-energy X-ray absorptiometry scan


Secondary Outcome Measures :
  1. change in hand grip strength [ Time Frame: from 6 months to 1 year ]
    measured by dynamometer

  2. change in the physical function score [ Time Frame: from 6 months to 1 year ]
    measured by Standard-Form 36 version 2


Other Outcome Measures:
  1. change in serum albumin [ Time Frame: from 6 months to 1 year ]
    change in serum albumin

  2. change in dietary intake [ Time Frame: from 6 months to 1 year ]
    measured by a food frequency questionnaire

  3. change in anthropometric measures [ Time Frame: from 6 months to 1 year ]
    triceps skinfold thickness, mid arm circumference, and weight

  4. change in serum cholesterol [ Time Frame: from 6 months to 1 year ]
    change in serum cholesterol



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043144


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Katherine Lynch, MD, SM Beth Israel Deaconess Medical Center

Responsible Party: Katherine Lynch, Instructor in Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03043144     History of Changes
Other Study ID Numbers: 2016P000152
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Kidney Diseases
Taste Disorders
Olfaction Disorders
Urologic Diseases
Nutrition Disorders
Sensation Disorders
Nervous System Diseases
Kidney Failure, Chronic
Malnutrition
Renal Insufficiency
Pathologic Processes
Renal Insufficiency, Chronic
Neurologic Manifestations
Signs and Symptoms