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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01896882
Other study ID # UFRGS and HCPA - 120109
Secondary ID
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


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
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