Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT

June 13, 2017 updated by: Maya N. Clark-Cutaia, University of Pennsylvania
Dietary sodium intake independently increases the risk of mortality in end stage renal disease (ESRD). It plays a significant role in hypertension, hypervolemia, and left ventricular hypertrophy (LVH), and blunts the effectiveness of hypertensive agents. In addition, the hypervolemia associated with excessive dietary sodium intake results in the need for more intense fluid removal during dialysis (ultrafiltration), resulting in symptoms such as pain, cramps, hypotension, nausea, and vomiting during hemodialysis (HD) treatment sessions. Although sodium restriction is a universal recommendation for ESRD management, the National Kidney Foundation (NKF) recommendation of 2400 mg/day is consensus-based per the Dietary Approaches to Stop Hypertension (DASH) studies, not an evidence-based recommendation from data derived from a dialysis population. In addition, The Dietary Guidelines for Americans 2010, recommend further restriction of dietary sodium intake to 1500 mg per day for persons with hypertension and/or kidney disease, middle-aged and older adults, and African Americans, though there is also little empiric evidence to support this recommendation in the general population and none in the dialysis population. Therefore, it remains to be demonstrated that a diet with such sodium restrictions is attainable, sustainable, safe or beneficial. The investigators propose a double blind randomized controlled design investigation to examine the feasibility of assessing the effects of three levels of sodium intake (ambient, 2400 mg/d, 1500 mg/d) on the hemodialysis (HD) participant symptom profile, and to compare the effect of hemodialysis-specific variables on participant symptom profile during dialysis as well as to explore the role of body fluid composition using bioimpedance (BIA) measurements among the three sodium-restricted groups as a marker of sodium restriction efficacy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. persons ≥ 21 years of age
  2. who have the ability to read and write,
  3. who are undergoing maintenance HD
  4. who are on therapy for at least 3 months.

Exclusion Criteria:

  1. unable to read or write
  2. non-English speaking
  3. intend to move out of the area or change HD centers within 6 months
  4. have terminal illness or life expectancy of less than 12 months,
  5. plan to receive a living donor transplant in the study period, have cognitive impairment
  6. are unable to provide informed consent
  7. have heart Failure Class III or IV
  8. have an internal defibrillator or pacemaker, and/or are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sodium Restriction 1500mg Group
During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.
Dietary supplement: Sodium Restriction
Active Comparator: Sodium Restriction 2400mg Group
During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.
Dietary supplement: Sodium Restriction
No Intervention: Control Group
During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Interdialytic Weight Gain
Time Frame: 5 days
IDWG is defined as the difference in weight in kilograms between measurement at time 1 (immediately following HD) and time 2 (immediately prior to the next HD session).4 Weights will be obtained in the aforementioned fashion in the CTRC, and calculated by the CTRC nursing core staff. The PI will train CTRC personnel on IDWG calculations.
5 days
Palliative Care Outcomes Scale-Renal
Time Frame: 3-5 days
The POS is a survey used to measure health related QOL in the short term.68, 69 It reviews the symptoms listed in the KDQOL-36, however, the respondent refers to these symptoms in the short-term, the last three days
3-5 days
Body Composition
Time Frame: 5 days
Body composition will be measured with bioimpedance spectroscopy (BIS; ImpediMed® Imp_ SFB7, ImpediMed Limited, Queensland, Australia). Measurements include TBW, ECF, and ICF (in liters). We will take three consecutive measurements on the external surface of the skin by placing electrodes on the right hand and right foot. BIS has been shown good correlation with biochemical markers, such as the gold standard tracers methods (R2=0.93) when measuring ECF62, 63, but may have better clinical application due to its ease of use, reproducibility, and the fact that biochemical markers are costly and require vast amounts of training to perform, limiting the availability of analysis centers.
5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Pressure.
Time Frame: 5 days
An oscillometric device, fitted with an appropriate cuff, will be used to measure mean systolic and mean diastolic pressure in the CTRC in accordance with World Health Organization guidelines.61 These same guidelines will be used by DaVita Dialysis center staff during blood pressure measurements. DaVita nursing will be trained by the PI to ensure adherence to blood pressure measurement protocols
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 819779

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