Chitosan Chewing Gum Study in Dialysis Patients | NCT01770470

Studies
Chitosan Chewing Gum Study in Dialysis Patients

NCT01770470

Sponsor

University of Maryland, Baltimore

Status

Completed

Last Update Posted

Jun 23, 2021Actual

Enrollment

15Actual

Phase

Not provided

Conditions

End Stage Renal Disease

Interventions

Chitosan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 15, 2013

First Submission Date that Met QC Criteria

Jan 15, 2013

First Posted Date

Jan 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2021

Last Update Posted Date

Jun 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving chronic hemodialysis		Dialysis patients chewing chitosan-containing gum	Dietary Supplement: Chitosan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chitosan	Dietary Supplement	The product chitosan is contained in a chewing gum formulation	Patients receiving chronic hemodialysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unable to sign consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Outpatient hemodialysis facility

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Dowling, PhD	University of Maryland, Baltimore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland		Baltimore	Maryland	21201	United States

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D048271	Chitosan

Ancestor Terms

ID	Term
D002686	Chitin
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided