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Completed

NCT Number: NCT01770470

Chitosan Chewing Gum Study 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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to sign consent

Treatment and study plan

Chitosan

Dietary Supplement

The product chitosan is contained in a chewing gum formulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

A Pilot Study of Dietary Chitosan Chewing Gum in Dialysis Patients

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jan 17, 2013
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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