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CompletedNCT01770470Updated Jun 23, 2021

Chitosan Chewing Gum Study in Dialysis Patients

An observational study in End Stage Renal Disease, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by University of Maryland, Baltimore · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 64 Years
Sex
All
01

Study summary

The purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

Read the detailed description

The impact of using salivary phosphate binders in ESRD patients is not fully known. The purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

02

Conditions studied

  • End Stage Renal Disease

Keywords

  • serum phosphate
  • chitosan
  • kidney disease
  • salivary phosphate
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 15 is below the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Outpatient hemodialysis facility

Inclusion criteria

  • Age 18-64 years old
  • ESRD receiving hemodialysis
  • serum phosphate > 6.0 mg/dL

Exclusion criteria

Exclusion Criteria:

  • Unable to sign consent
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (actual)

Groups and cohorts

  • Patients receiving chronic hemodialysis

    Dialysis patients chewing chitosan-containing gum

    Dietary Supplement: Chitosan

Interventions

  • Dietary supplementChitosan

    The product chitosan is contained in a chewing gum formulation

06

What researchers measure

Primary outcomes

  1. Serum phosphate

    Serum phosphate will be drawn 3 times per week over 2 weeks (during gum therapy), then once at 4 weeks and once at 6 weeks.

    Time frame: 6 weeks

Secondary outcomes

  1. Salivary phosphate levels

    Salivary phosphate will be assessed 3 times per week over 2 weeks (during gum therapy), then once at 4 weeks and once at 6 weeks.

    Time frame: 6 weeks

07

Study locations

1 site
  • University of Maryland
    Baltimore, Maryland 21201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01770470
Lead sponsor
University of Maryland, Baltimore
Responsible party
Sponsor
First posted
Jan 17, 2013
Start date
Apr 2010
Primary completion
Dec 2010
Completion
Jan 2011
Last update
Jun 23, 2021

Study contacts

Thomas Dowling, PhD
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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