NCT01770470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

January 15, 2013

Last Update Submit

June 17, 2021

Conditions

End Stage Renal Disease

Keywords

serum phosphatechitosankidney diseasesalivary phosphate

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Salivary phosphate levels

    6 weeks

Study Arms (1)

Patients receiving chronic hemodialysis

Dialysis patients chewing chitosan-containing gum

Dietary Supplement: Chitosan

Interventions

ChitosanDIETARY_SUPPLEMENT

The product chitosan is contained in a chewing gum formulation

Patients receiving chronic hemodialysis

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Outpatient hemodialysis facility

You may qualify if:

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

You may not qualify if:

  • Unable to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicKidney Diseases

Interventions

Chitosan

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChitinBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Study Officials

  • Thomas Dowling, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

US(1)