Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients
|ClinicalTrials.gov Identifier: NCT01458808|
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Objective: To evaluate the influence of dietary sodium reduction on body fluid volume and inflammatory state in hemodialysis (HD) patients.
Design: Prospective controlled randomized study. Setting: Dialysis Unit of Botucatu Medical School Hospital, Sao Paulo State University, Brazil.
Patients: Adult patients on HD for at least 30 days and C-reactive protein (CRP) ≥ 0.7 mg/dl were randomly allocated into two groups: Group A: 21 patients treated with a 2g sodium restriction in their habitual diet, and Group B: 18 controls. Inflammatory, biochemical, hematological and nutritional markers, as well as dialysis dosage were assessed at baseline and after 8 and 16 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Stage 5||Other: Dietary sodium restriction Other: Dialysate sodium concentration reduction||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients. A Prospective Randomized Controlled Study|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Experimental: Group A
Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.
Other: Dietary sodium restriction
Restriction of 2 grams on daily sodium diet intake.
Other Name: Dietary prescription
Experimental: Group B
Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L
Other: Dialysate sodium concentration reduction
Reduction of dialysate sodium concentration from 138 to 135 mEq/L
Other Name: Dialysis prescription
No Intervention: Group C
Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.
- C-reactive protein [ Time Frame: up to 16 weeks ]The outcome will be evaluates each eight weeks
- interleukin-6 [ Time Frame: up to 16 weeks ]The outcome will be evaluates each eight weeks
- alpha tumor necrosis serum concetrations [ Time Frame: up to 16 weeks ]The outcome will be evaluates each eight weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458808
|Principal Investigator:||Lidiane R. Telini, MSC||UPECLIN HC FM Botucatu Unesp|