Chitosan Chewing Gum Study in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Dowling, University of Maryland
ClinicalTrials.gov Identifier:
NCT01770470
First received: January 15, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Serum phosphate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Other Name: Chitosan

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Baltimore County
  More Information

No publications provided

Responsible Party: Thomas Dowling, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01770470     History of Changes
Other Study ID Numbers: HP-00045129
Study First Received: January 15, 2013
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 29, 2014