End Stage Renal Disease
Conditions
Keywords
serum phosphate, chitosan, kidney disease, salivary phosphate
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.
Interventions
DIETARY_SUPPLEMENTChitosan
The product chitosan is contained in a chewing gum formulation
Sponsors
University of Maryland, Baltimore
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-64 years old * ESRD receiving hemodialysis * serum phosphate \> 6.0 mg/dL
Exclusion criteria
* Unable to sign consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed