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NCT01770470 Clinical Trial

Chitosan Chewing Gum Study in Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:
A Pilot Study of Dietary Chitosan Chewing Gum in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01770470
Other study ID # HP-00045129
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2010
Est. completion date January 2011

Study information
Verified date June 2021
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date January 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Age 18-64 years old - ESRD receiving hemodialysis - serum phosphate > 6.0 mg/dL Exclusion Criteria: - Unable to sign consent

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Chitosan
The product chitosan is contained in a chewing gum formulation

Locations
Country Name City State
United States University of Maryland Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 weeks
Secondary 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. 6 weeks
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