NCT01458808

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

1.8 years

First QC Date

June 14, 2011

Last Update Submit

October 24, 2011

Conditions

Chronic Kidney Diseases Stage 5

Keywords

saltinflammationhypervolemiadiet

Outcome Measures

Primary Outcomes (3)

  • C-reactive protein

    The outcome will be evaluates each eight weeks

    up to 16 weeks

  • interleukin-6

    The outcome will be evaluates each eight weeks

    up to 16 weeks

  • alpha tumor necrosis serum concetrations

    The outcome will be evaluates each eight weeks

    up to 16 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.

Other: Dietary sodium restriction

Group B

EXPERIMENTAL

Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L

Other: Dialysate sodium concentration reduction

Group C

NO INTERVENTION

Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.

Interventions

Dietary sodium restrictionOTHER

Restriction of 2 grams on daily sodium diet intake.

Also known as: Dietary prescription
Group A
Dialysate sodium concentration reductionOTHER

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

Also known as: Dialysis prescription
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • included patients aged ≥ 18 years who had been on hemodialysis for at least 90 days, and were diagnosed with inflammation. Inflammation was defined as C Reactive Protein ≥ 0.7 mg/dL

You may not qualify if:

  • acute inflammatory processes confirmed by clinical criteria and/or complementary tests
  • acute inflammatory diseases
  • tuberculosis
  • use of antibiotics within the past two months
  • chronic inflammatory diseases
  • neoplasias
  • chronic obstructive pulmonary disease
  • use of central venous catheter and positive HIV serology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

    PMID: 39498822DERIVED

  • McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

    PMID: 34164803DERIVED

MeSH Terms

Conditions

InflammationEdema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Lidiane R. Telini, MSC

    UPECLIN HC FM Botucatu Unesp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSC

Study Record Dates

First Submitted

June 14, 2011

First Posted

October 25, 2011

Study Start

April 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 25, 2011

Record last verified: 2011-10