Chitosan Chewing Gum Study in Dialysis Patients

University of Maryland, Baltimore15 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

End Stage Renal Disease

Interventions

ChitosanDIETARY_SUPPLEMENT

The product chitosan is contained in a chewing gum formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-64 years old * ESRD receiving hemodialysis * serum phosphate \> 6.0 mg/dL Exclusion Criteria: * Unable to sign consent

Locations (1)

University of Maryland

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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