ESRDNCT02778516
Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT
A study testing Sodium Restriction in people with ESRD, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- ESRD
- What is being tested?
- Sodium Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2016
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- persons ≥ 21 years of age
- who have the ability to read and write,
- who are undergoing maintenance HD
- who are on therapy for at least 3 months.
Who cannot join
- unable to read or write
- non-English speaking
- intend to move out of the area or change HD centers within 6 months
- have terminal illness or life expectancy of less than 12 months,
- plan to receive a living donor transplant in the study period, have cognitive impairment
- are unable to provide informed consent
- have heart Failure Class III or IV
- have an internal defibrillator or pacemaker, and/or are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Nursing
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- ESRD
- Being tested
- Sodium Restriction
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium RestrictionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sodium Restriction 1500mg Group | Active comparator | 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. Receives: Dietary Supplement: Sodium Restriction |
| Sodium Restriction 2400mg Group | Active comparator | 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. Receives: Dietary Supplement: Sodium Restriction |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Interdialytic Weight Gain
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.
Measured: 5 days
Palliative Care Outcomes Scale-Renal
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
Measured: 3-5 days
Body Composition
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.
Measured: 5 days
Secondary outcomes (1)
Blood Pressure.
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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Maya N. Clark-Cutaia, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778516
- Sponsor's protocol ID
- 819779
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2015
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT
- ClinicalTrials.gov ID
- NCT02778516
- Acronym / sponsor ID
- 819779
- Conditions
- ESRD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Aug 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 May 2016 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium Restriction 1500mg Group | Active comparator | Dietary Supplement: Sodium RestrictionDuring 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. |
| Sodium Restriction 2400mg Group | Active comparator | Dietary Supplement: Sodium RestrictionDuring 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- persons ≥ 21 years of age
- who have the ability to read and write,
- who are undergoing maintenance HD
- who are on therapy for at least 3 months.
Key exclusion criteria (8 listed)
- unable to read or write
- non-English speaking
- intend to move out of the area or change HD centers within 6 months
- have terminal illness or life expectancy of less than 12 months,
- plan to receive a living donor transplant in the study period, have cognitive impairment
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 | Dietary supplement | Sodium Restriction 1500mg Group, Sodium Restriction 2400mg Group |
Primary outcome
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.
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
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.
1 secondary outcome
Blood Pressure.
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ESRD, run by University of Pennsylvania at 1 site in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jun 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interdialytic Weight Gain (time frame: 5 days). The study lists 3 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 15 Jun 2017.