- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770470
Chitosan Chewing Gum Study in Dialysis Patients
June 17, 2021 updated by: University of Maryland, Baltimore
A Pilot Study of Dietary Chitosan Chewing Gum in Dialysis Patients
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Outpatient hemodialysis facility
Description
Inclusion Criteria:
- Age 18-64 years old
- ESRD receiving hemodialysis
- serum phosphate > 6.0 mg/dL
Exclusion Criteria:
- Unable to sign consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients receiving chronic hemodialysis
Dialysis patients chewing chitosan-containing gum
|
The product chitosan is contained in a chewing gum formulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum phosphate
Time Frame: 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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary phosphate levels
Time Frame: 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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Dowling, PhD, University of Maryland, Baltimore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
January 15, 2013
First Submitted That Met QC Criteria
January 15, 2013
First Posted (Estimate)
January 17, 2013
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hemostatics
- Coagulants
- Chelating Agents
- Sequestering Agents
- Chitosan
Other Study ID Numbers
- HP-00045129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Renal Disease
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
University of Illinois at ChicagoWithdrawnObesity | End-Stage Renal Disease | Renal Disease, End-Stage | Renal Failure, End-StageUnited States
-
Bioconnect Systems, IncCompletedEnd-stage Renal Disease | End-stage Kidney DiseaseUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...Changhai Hospital; Shanghai Zhongshan Hospital; RenJi Hospital; Ruijin Hospital; Shanghai... and other collaboratorsCompleted
-
Clinical Research Center for End Stage Renal Disease...Kyungpook National University Hospital; Medical Research Collaborating Center... and other collaboratorsActive, not recruitingEnd-Stage Renal DiseaseKorea, Republic of
-
Medtronic - MITGCompletedEnd-stage Renal DiseaseGermany
-
China Medical University HospitalUnknown
-
Guangdong Provincial Hospital of Traditional Chinese...Ministry of Science and Technology of the People´s Republic of ChinaUnknown
-
University of California, San FranciscoCompletedEnd-stage Renal DiseaseUnited States
-
Mark A. LumleyHenry Ford Health SystemCompleted
Clinical Trials on Chitosan
-
Denver Nephrologists, P.C.CM&D Pharma LimitedCompletedChronic Kidney DiseaseUnited States
-
Caspar WohlfahrtDr Caspar Wohlfahrt; Dr Maria BaltaRecruitingPeriodontitis | Periodontal Diseases | Periodontal Pocket | Periodontal InflammationNorway
-
Universidade do PortoUniversidade Católica PortuguesaCompletedAtopic DermatitisPortugal
-
Cairo UniversityUnknown
-
University of OsloCompletedPeri-implant Mucositis | Periimplantitis
-
Chulalongkorn UniversityCompletedSafety Issues | Pressure SoreThailand
-
Chulalongkorn UniversityPolice General HospitalUnknown
-
DNP CanadaJSS Medical Research Inc.CompletedHypercholesterolemiaCanada
-
Aristotle University Of ThessalonikiCompleted
-
Tri-Service General HospitalNational Defense Medical Center, TaiwanCompleted