Chitosan Chewing Gum Study in Dialysis Patients

NCT ID: NCT01770470

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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End Stage Renal Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving chronic hemodialysis

Dialysis patients chewing chitosan-containing gum

Chitosan

Intervention Type DIETARY_SUPPLEMENT

The product chitosan is contained in a chewing gum formulation

Interventions

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Chitosan

The product chitosan is contained in a chewing gum formulation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to sign consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Dowling, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00045129

Identifier Type: -

Identifier Source: org_study_id

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