Hemodialysis PatientsNCT01896882
Dietary Sodium Restriction in Hemodialysis Patients
A study testing Sodium restriction in people with Hemodialysis Patients, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Sodium restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study.
Who cannot join
- Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003
About this study
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.
- Conditions
- Hemodialysis Patients
- Being tested
- Sodium restriction
- Keywords
- Diet, Sodium-Restricted, Food and Nutrition Education, Renal Dialyisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium restrictionOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Nutritional education on sodium restriction diet. Receives: Other: Sodium restriction |
| Control | No intervention | Standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium intake
Sodium intake will be evaluated by food record and a food frequency questionnaire.
Measured: 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.
Measured: Baseline, 180 and 360 days.
Secondary outcomes (1)
Interdialytic weight gain
Will be considered the amount of weight gain between 2 dialysis sessions.
Measured: Baseline, 30, 90, 180 and 360 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriela Corrêa Souza, Professor, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896882
- Sponsor's protocol ID
- UFRGS and HCPA - 120109
- Status last verified
- Feb 2012
- First submitted
- 8 Jul 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Sodium Restriction in Hemodialysis Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01896882
- Acronym / sponsor ID
- UFRGS and HCPA - 120109
- Conditions
- Hemodialysis Patients
- Keywords
- Diet, Sodium-Restricted, Food and Nutrition Education, Renal Dialyisis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sodium restrictionNutritional education on sodium restriction diet. |
| Control | No intervention | –Standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study.
Key exclusion criteria (1 listed)
- Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium restriction | Other | Intervention |
Primary outcome
Sodium intake
Time frame: Baseline, 30, 90, 180 and 360 days
Sodium intake will be evaluated by food record and a food frequency questionnaire.
Quality of life
Time frame: Baseline, 180 and 360 days.
Quality of life will be evaluated by the Brazilian Portuguese version of the Kidney Disease and Quality-of-Life Short-Form (KDQOL-SF) questionnaire.
1 secondary outcome
Interdialytic weight gain
Time frame: Baseline, 30, 90, 180 and 360 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Corrêa Souza, Professor principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium restriction in people with Hemodialysis Patients, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium intake (time frame: Baseline, 30, 90, 180 and 360 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.