Helping Olfaction and Nutrition On Renal Replacement

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    20
  • sponsor
    Massachusetts General Hospital
Updated on 26 January 2021
kidney replacement

Summary

This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.

Description

Malnutrition and cachexia are prevalent in end stage renal disease (ESRD) patients and are associated with increased morbidity and mortality. Food aversion is a major contributor to anorexia and malnutrition in ESRD and it also impacts the quality of life. Olfactory dysfunction has been shown to contribute to food aversion in ESRD patients. Since up to 80% of a meal's flavor is attributed to olfactory input, loss or alteration of smell leads to loss or alteration of taste in ESRD patients and at present there are no effective therapies to treat smell and/or taste disorders in ESRD patients.

In patients with other causes of olfactory dysfunction such as congenital hyposmia and traumatic brain injury, intranasal theophylline has been shown to be effective in improving olfactory defects via increasing nasal mucus levels of cAMP and cGMP, second messengers critical for optimal smell sensation. However, the efficacy of nasal theophylline to improve olfaction in ESRD patients has not been investigated and the effects of nasal theophylline treatment on the nutritional parameters are unknown in ESRD patients.

Aim: To examine the efficacy and safety of nasal theophylline treatment to improve olfaction and nutrition in ESRD patients

Hypothesis: Nasal theophylline treatment improves olfaction and nutrition in ESRD patients with olfactory defects by via increasing intracellular cAMP and cGMP levels.

A previous pilot clinical trial demonstrated that intranasal theophylline is safe and effective in improving olfactory deficits in congenital hyposmia and traumatic brain injury, however, it has not been examined in ESRD patients. The investigators will conduct a pilot single arm open-label clinical trial (n=20) of 6 weeks duration to examine the efficacy and safety of nasal theophylline in hemodialysis-dependent ESRD patients with olfactory defects. The investigators will examine whether nasal theophylline improves olfaction and nutritional status in trial participants.

Details
Condition Chronic renal failure, Olfactory Disorders, Stage 5 Chronic Kidney Disease, Chronic Kidney Disease Stage 5, CKD Stage 5, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment Theophylline, Theophylline
Clinical Study IdentifierNCT02479451
SponsorMassachusetts General Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ESRD requiring chronic outpatient hemodialysis
Able to provide written consent
Defects in smell identification and/or smell threshold detection as measured by "Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and Smell Threshold Test

Exclusion Criteria

Prior allergic reaction to theophylline
Patients currently treated with theophylline for clinical indication
Pregnancy or lactation
ESRD patients on peritoneal dialysis
Patients hospitalized at the time of study enrollment
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