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Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients

NCT01458808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2011-10-25

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Diseases Stage 5

Interventions

OTHER

Dietary sodium restriction

Restriction of 2 grams on daily sodium diet intake.

OTHER

Dialysate sodium concentration reduction

Reduction of dialysate sodium concentration from 138 to 135 mEq/L

Sponsors & Collaborators

  • UPECLIN HC FM Botucatu Unesp

    lead OTHER

Principal Investigators

  • Lidiane R. Telini, MSC · UPECLIN HC FM Botucatu Unesp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-02-28
Completion
2009-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458808 on ClinicalTrials.gov