NCT01651975

Brief Summary

Dysphagia is extremely common. The importance of providing adequate nutritional support to persons with dysphagia is the cornerstone to exceptional care. Diet modification with thickening agents is an essential aspect of this nutritional support. The purpose of this investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based thickening agent (Thickenup Advance or TUA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

January 24, 2012

Last Update Submit

May 25, 2017

Conditions

Dysphagia

Keywords

DysphagiaThickening liquidThickening agentFluoroscopic swallow studyAspirationHistory of dysphagiaDSSAge > 18comprehensive DSSinformed consent

Outcome Measures

Primary Outcomes (1)

  • Compare aspiration risk

    Compare the prevalence of aspiration risk with TUA to the prevalence of aspiration risk with TU and thin liquid barium at the time the subject undergoes a fluoroscopic swallowing study

    Time of intervention

Study Arms (1)

Thickenup

OTHER
Dietary Supplement: ThickenupDietary Supplement: Thickenup Advance

Interventions

ThickenupDIETARY_SUPPLEMENT

given two 1-cc boluses of liquid contrast agent (barium), one 3-cc of thin liquid contrast, one 3-cc of paste, one cookie with contrast, one 20-cc bolus of liquid contrast, and one 20-cc bolus of thin liquid contrast. The patients are then studied in the anterior/posterior view with one 1-cc, one 3-cc, and one 20-cc bolus of thin liquid barium 1-4. At the end of the protocol patients are routinely administered products with either starch or gel based thickener to evaluate the swallowing safety of the thickened agent. The protocol includes a 3-minute limitation on total fluoroscopy time to ensure clinician and patient safety.

Also known as: Liquid E-Z-Paque, E-Z-Em, Inc.
Thickenup
Thickenup AdvanceDIETARY_SUPPLEMENT

given two 1-cc boluses of liquid contrast agent (barium), one 3-cc of thin liquid contrast, one 3-cc of paste, one cookie with contrast, one 20-cc bolus of liquid contrast, and one 20-cc bolus of thin liquid contrast. The patients are then studied in the anterior/posterior view with one 1-cc, one 3-cc, and one 20-cc bolus of thin liquid barium 1-4. At the end of the protocol patients are routinely administered products with either starch or gel based thickener to evaluate the swallowing safety of the thickened agent. The protocol includes a 3-minute limitation on total fluoroscopy time to ensure clinician and patient safety.

Also known as: Liquid E-Z Paque, E-Z-EM, Inc
Thickenup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of dysphagia necessitating a dynamic fluoroscopic swallow study
  • Age \> 18 years
  • Ability to complete a comprehensive dynamic fluoroscopic swallow study
  • Ability to provide informed consent for study participation

You may not qualify if:

  • Age \< 18 years
  • Pregnant women
  • Prisoner or other institutionalized individual
  • Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Peter Belafsky, MD, Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

July 27, 2012

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)