Hemodialysis Patients Clinical Trial
Official title:
Effects of Dietary Sodium Restriction in Hemodialysis Patients: Randomized Clinical Trial
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.
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
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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