Chitosan Chewing Gum Study in Dialysis Patients

Completed

• Conditions: End Stage Renal Disease
• Interventions: Dietary Supplement: Chitosan

• Registration Number: NCT01770470
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• Unable to sign consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving chronic hemodialysis	Chitosan	Dialysis patients chewing chitosan-containing gum

Primary Outcome Measures

Name	Time	Method
Serum phosphate	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

Name	Time	Method
Salivary phosphate levels	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.

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States