<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043144</url>
  </required_header>
  <id_info>
    <org_study_id>2016P000152</org_study_id>
    <nct_id>NCT03043144</nct_id>
  </id_info>
  <brief_title>Taste And Smell TEsting in End Stage Renal Disease</brief_title>
  <acronym>TASTE ESRD</acronym>
  <official_title>TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malnutrition is an important complication of advanced kidney disease and impairment in smell&#xD;
      and taste may affect nutritional status. This study will examine the association between&#xD;
      impairment in smell and taste and nutritional and functional markers among patients with end&#xD;
      stage renal disease, as well as risk factors for smell and taste impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with advanced chronic kidney disease (CKD) are at risk for malnutrition, which is&#xD;
      associated with significantly increased mortality. Impairments in olfaction and taste are&#xD;
      under-recognized and under-addressed symptoms that affect this population. Olfaction and&#xD;
      taste influence appetite and nutritional status and represent a unique target for study and&#xD;
      intervention. Small cross-sectional studies have shown a higher prevalence of olfactory (up&#xD;
      to 56%) and taste disturbances (up to 35%) among patients with CKD compared with the general&#xD;
      population, but little is known about longitudinal change in olfaction and taste in this&#xD;
      population. Additionally, there is a lack of understanding about why these sensory&#xD;
      disturbances more commonly occur in people with CKD, although there is speculation that&#xD;
      uremia may contribute.&#xD;
&#xD;
      This information gained from this study will address these gaps in knowledge by studying&#xD;
      longitudinal changes in olfaction and taste and their associations with concurrent and future&#xD;
      nutritional and functional status. Additionally this study will attempt to identify&#xD;
      potentially modifiable risk factors associated with olfactory and taste impairment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Investigator leaving the institution&#xD;
  </why_stopped>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in lean body mass</measure>
    <time_frame>from 6 months to 1 year</time_frame>
    <description>lean body mass will be determined by dual-energy X-ray absorptiometry scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in hand grip strength</measure>
    <time_frame>from 6 months to 1 year</time_frame>
    <description>measured by dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in the physical function score</measure>
    <time_frame>from 6 months to 1 year</time_frame>
    <description>measured by Standard-Form 36 version 2</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change in serum albumin</measure>
    <time_frame>from 6 months to 1 year</time_frame>
    <description>change in serum albumin</description>
  </other_outcome>
  <other_outcome>
    <measure>change in dietary intake</measure>
    <time_frame>from 6 months to 1 year</time_frame>
    <description>measured by a food frequency questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>change in anthropometric measures</measure>
    <time_frame>from 6 months to 1 year</time_frame>
    <description>triceps skinfold thickness, mid arm circumference, and weight</description>
  </other_outcome>
  <other_outcome>
    <measure>change in serum cholesterol</measure>
    <time_frame>from 6 months to 1 year</time_frame>
    <description>change in serum cholesterol</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Olfaction Disorders</condition>
  <condition>Taste Disorders</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>End stage renal disease</arm_group_label>
    <description>Observational study, no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Worsening of olfaction from enrollment visit to 6 months</intervention_name>
    <description>Worsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes</description>
    <arm_group_label>End stage renal disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Worsening of taste from enrollment visit to 6 months</intervention_name>
    <description>Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes</description>
    <arm_group_label>End stage renal disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serum Zinc</intervention_name>
    <description>Serum zinc will be evaluated for association with taste and/or smell impairment</description>
    <arm_group_label>End stage renal disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chronic rhinosinusitis</intervention_name>
    <description>Chronic rhinosinusitis will be evaluated for association with smell impairment</description>
    <arm_group_label>End stage renal disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dialysis adequacy</intervention_name>
    <description>Dialysis adequacy will be evaluated for association with taste and/or smell impairment</description>
    <arm_group_label>End stage renal disease</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decayed missing filled teeth index (DMFT)</intervention_name>
    <description>DMFT will be evaluated for association with taste impairment</description>
    <arm_group_label>End stage renal disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  End-stage renal disease requiring chronic dialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to quinine&#xD;
&#xD;
          -  Presence of a pacemaker or internal defibrillator&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Lynch, MD, SM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Katherine Lynch</investigator_full_name>
    <investigator_title>Instructor in Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Taste Disorders</mesh_term>
    <mesh_term>Olfaction Disorders</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043144
org study id: 2016P000152
nct id: NCT03043144
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: change in lean body mass
time frame: from 6 months to 1 year
description: lean body mass will be determined by dual-energy X-ray absorptiometry scan
measure: change in hand grip strength
time frame: from 6 months to 1 year
description: measured by dynamometer
measure: change in the physical function score
time frame: from 6 months to 1 year
description: measured by Standard-Form 36 version 2
measure: change in serum albumin
time frame: from 6 months to 1 year
description: change in serum albumin
measure: change in dietary intake
time frame: from 6 months to 1 year
description: measured by a food frequency questionnaire
measure: change in anthropometric measures
time frame: from 6 months to 1 year
description: triceps skinfold thickness, mid arm circumference, and weight
measure: change in serum cholesterol
time frame: from 6 months to 1 year
description: change in serum cholesterol
arm group label: End stage renal disease
description: Observational study, no intervention
intervention type: Other
intervention name: Worsening of olfaction from enrollment visit to 6 months
description: Worsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes
arm group label: End stage renal disease
intervention type: Other
intervention name: Worsening of taste from enrollment visit to 6 months
description: Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes
arm group label: End stage renal disease
intervention type: Other
intervention name: Serum Zinc
description: Serum zinc will be evaluated for association with taste and/or smell impairment
arm group label: End stage renal disease
intervention type: Other
intervention name: Chronic rhinosinusitis
description: Chronic rhinosinusitis will be evaluated for association with smell impairment
arm group label: End stage renal disease
intervention type: Other
intervention name: Dialysis adequacy
description: Dialysis adequacy will be evaluated for association with taste and/or smell impairment
arm group label: End stage renal disease
intervention type: Other
intervention name: Decayed missing filled teeth index (DMFT)
description: DMFT will be evaluated for association with taste impairment
arm group label: End stage renal disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine Lynch, MD, SM
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Katherine Lynch
investigator title: Instructor in Medicine
mesh term: Taste Disorders
mesh term: Olfaction Disorders
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency
mesh term: Malnutrition
sharing ipd: Undecided