NCT03043144

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

February 2, 2017

Last Update Submit

June 22, 2017

Conditions

Kidney Failure, ChronicOlfaction DisordersTaste DisordersMalnutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • change in hand grip strength

    from 6 months to 1 year

  • change in the physical function score

    from 6 months to 1 year

Other Outcomes (4)

  • change in serum albumin

    from 6 months to 1 year

  • change in dietary intake

    from 6 months to 1 year

  • change in anthropometric measures

    from 6 months to 1 year

  • +1 more other outcomes

Study Arms (1)

End stage renal disease

Observational study, no intervention

Other: Worsening of olfaction from enrollment visit to 6 monthsOther: Worsening of taste from enrollment visit to 6 monthsOther: Serum ZincOther: Chronic rhinosinusitisOther: Dialysis adequacyOther: Decayed missing filled teeth index (DMFT)

Interventions

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

End stage renal disease
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

End stage renal disease
Serum ZincOTHER

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

End stage renal disease
Chronic rhinosinusitisOTHER

Chronic rhinosinusitis will be evaluated for association with smell impairment

End stage renal disease
Dialysis adequacyOTHER

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

End stage renal disease
Decayed missing filled teeth index (DMFT)OTHER

DMFT will be evaluated for association with taste impairment

End stage renal disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (aged 18 or older) who have end-stage renal disease requiring chronic dialysis.

You may qualify if:

  • Aged 18 or older
  • End-stage renal disease requiring chronic dialysis

You may not qualify if:

  • Known allergy to quinine
  • Presence of a pacemaker or internal defibrillator
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicOlfaction DisordersTaste DisordersMalnutrition

Interventions

c-MYC-associated zinc finger protein

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Katherine Lynch, MD, SM

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Medicine

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 3, 2017

Study Start

February 15, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations

US(1)