Kidney Failure, ChronicTASTE ESRDNCT03043144
Taste And Smell TEsting in End Stage Renal Disease
An observational study of Kidney Failure, Chronic and Olfaction Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Olfaction Disorders, Taste Disorders
- What is being tested?
- Worsening of olfaction from enrollment visit to 6 months, Worsening of taste from enrollment visit to 6 months and Serum Zinc
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.
Who may be able to join
- Aged 18 or older
- End-stage renal disease requiring chronic dialysis
Who cannot join
- Known allergy to quinine
- Presence of a pacemaker or internal defibrillator
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease
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.
Read the 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.
- Being tested
- Worsening of olfaction from enrollment visit to 6 months, Worsening of taste from enrollment visit to 6 months, Serum Zinc, Chronic rhinosinusitis, Dialysis adequacy
- Medical subject headings
- Kidney Failure, Chronic, Olfaction Disorders, Taste Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worsening of olfaction from enrollment visit to 6 monthsOther
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 monthsOther
Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes
Serum ZincOther
Serum zinc will be evaluated for association with taste and/or smell impairment
Chronic rhinosinusitisOther
Chronic rhinosinusitis will be evaluated for association with smell impairment
Dialysis adequacyOther
Dialysis adequacy will be evaluated for association with taste and/or smell impairment
Decayed missing filled teeth index (DMFT)Other
DMFT will be evaluated for association with taste impairment
| Study group | Role | What they receive |
|---|---|---|
| End stage renal disease | Observational study, no intervention Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lean body mass
lean body mass will be determined by dual-energy X-ray absorptiometry scan
Measured: from 6 months to 1 year
Secondary outcomes (2)
change in hand grip strength
measured by dynamometer
Measured: from 6 months to 1 year
change in the physical function score
measured by Standard-Form 36 version 2
Measured: from 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start15 Feb 2017
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Why it stopped: Investigator leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Lynch, Beth Israel Deaconess Medical Center
- Investigators
- Katherine Lynch, MD, SM, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043144
- Sponsor's protocol ID
- 2016P000152
- Acronym
- TASTE ESRD
- Status last verified
- Jun 2017
- First submitted
- 2 Feb 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TASTE ESRD: Taste And Smell TEsting in End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT03043144
- Acronym / sponsor ID
- TASTE ESRD / 2016P000152
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator leaving the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End stage renal disease | – | 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)Observational study, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.
Key inclusion criteria (2 listed)
- Aged 18 or older
- End-stage renal disease requiring chronic dialysis
Key exclusion criteria (3 listed)
- Known allergy to quinine
- Presence of a pacemaker or internal defibrillator
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Worsening of olfaction from enrollment visit to 6 monthsWorsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes | Other | End stage renal disease |
| Worsening of taste from enrollment visit to 6 monthsWorsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes | Other | End stage renal disease |
| Serum ZincSerum zinc will be evaluated for association with taste and/or smell impairment | Other | End stage renal disease |
| Chronic rhinosinusitisChronic rhinosinusitis will be evaluated for association with smell impairment | Other | End stage renal disease |
| Dialysis adequacyDialysis adequacy will be evaluated for association with taste and/or smell impairment | Other | End stage renal disease |
| Decayed missing filled teeth index (DMFT)DMFT will be evaluated for association with taste impairment | Other | End stage renal disease |
Primary outcome
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
2 secondary outcomes
change in hand grip strength
Time frame: from 6 months to 1 year
change in the physical function score
Time frame: from 6 months to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Lynch, MD, SM principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Olfaction Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in lean body mass (time frame: from 6 months to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.