NCT01896882

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 11, 2013

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

July 8, 2013

Last Update Submit

July 8, 2013

Conditions

Hemodialysis Patients

Keywords

Diet, Sodium-RestrictedFood and Nutrition EducationRenal Dialyisis

Outcome Measures

Primary Outcomes (2)

  • Sodium intake

    Sodium intake will be evaluated by food record and a food frequency questionnaire.

    Baseline, 30, 90, 180 and 360 days

  • 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.

Secondary Outcomes (1)

  • Interdialytic weight gain

    Baseline, 30, 90, 180 and 360 days.

Study Arms (2)

Intervention

EXPERIMENTAL

Nutritional education on sodium restriction diet.

Other: Sodium restriction

Control

NO INTERVENTION

Standard treatment.

Interventions

Sodium restrictionOTHER
Intervention

Eligibility Criteria

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

You may qualify if:

  • Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study.

You may not qualify if:

  • Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

Study Officials

  • Gabriela Corrêa Souza, Professor

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 11, 2013

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

August 1, 2014

Last Updated

July 11, 2013

Record last verified: 2012-02

Locations

BR(1)