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Sodium Restriction in the Management of Cirrhotic Ascites

NCT00548366 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2010-09-14

No results posted yet for this study

Summary

To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.

Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.

Conditions

  • Ascites

Interventions

OTHER

Sodium restriction

4 gram sodium diet

OTHER

Sodium restriction

2 gram sodium diet

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Jennifer A Cuthbert, M.D. · UT Southwestern Medical Center at Dallas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-12-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548366 on ClinicalTrials.gov