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Clinical Trials/NCT01896882
NCT01896882
Unknown
Not Applicable

Effects of Dietary Sodium Restriction in Hemodialysis Patients: Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre1 site in 1 country112 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodialysis Patients
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
112
Locations
1
Primary Endpoint
Sodium intake
Last Updated
12 years ago

Overview

Brief Summary

Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased risk for cardiovascular diseases. These complications are associated with end stage renal disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the effects of nutritional counseling restricting dietary sodium and its relation to clinical and diet factors, nutritional knowledge and quality of life in hemodialysis patients.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
August 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study.

Exclusion Criteria

  • Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.

Outcomes

Primary Outcomes

Sodium intake

Time Frame: Baseline, 30, 90, 180 and 360 days

Sodium intake will be evaluated by food record and a food frequency questionnaire.

Quality of life

Time Frame: Baseline, 180 and 360 days.

Quality of life will be evaluated by the Brazilian Portuguese version of the Kidney Disease and Quality-of-Life Short-Form (KDQOL-SF) questionnaire.

Secondary Outcomes

  • Interdialytic weight gain(Baseline, 30, 90, 180 and 360 days.)

Study Sites (1)

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