Dietary Sodium Restriction in Hemodialysis Patients

Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01896882
• Other study ID #: UFRGS and HCPA - 120109
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 8, 2013
• Last updated: July 8, 2013
• Start date: March 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2012
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 112
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Other:
• Sodium restriction

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sodium intake	Sodium intake will be evaluated by food record and a food frequency questionnaire.	Baseline, 30, 90, 180 and 360 days	No
Primary	Quality of life	Quality of life will be evaluated by the Brazilian Portuguese version of the Kidney Disease and Quality-of-Life Short-Form (KDQOL-SF) questionnaire.	Baseline, 180 and 360 days.	No
Secondary	Interdialytic weight gain	Will be considered the amount of weight gain between 2 dialysis sessions.	Baseline, 30, 90, 180 and 360 days.	No