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Chitosan Chewing Gum Study in Dialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770470
First Posted: January 17, 2013
Last Update Posted: August 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Maryland
  Purpose
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.

Condition Intervention
End Stage Renal Disease Dietary Supplement: Chitosan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Dietary Chitosan Chewing Gum in Dialysis Patients

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Serum phosphate [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures:
  • Salivary phosphate levels [ Time Frame: 6 weeks ]
    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.


Enrollment: 15
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients receiving chronic hemodialysis
Dialysis patients chewing chitosan-containing gum
Dietary Supplement: Chitosan
The product chitosan is contained in a chewing gum formulation

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatient hemodialysis facility
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to sign consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770470


Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Thomas Dowling, PhD University of Maryland
  More Information

Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT01770470     History of Changes
Other Study ID Numbers: HP-00045129
First Submitted: January 15, 2013
First Posted: January 17, 2013
Last Update Posted: August 23, 2016
Last Verified: January 2013

Keywords provided by University of Maryland:
serum phosphate
chitosan
kidney disease
salivary phosphate

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants