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NCT02778516 · ClinicalTrials.gov registry record · NA
Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT
A NA study of ESRD, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT02778516 is a NA study of ESRD that has completed, run by University of Pennsylvania. The registered enrollment target is 42 participants, below the 138-participant average among 13 other ESRD trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02778516, a NA study of ESRD, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study 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. 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 Studied
Interventions
- DIETARY_SUPPLEMENT Sodium Restriction
Study Locations (1)
Pennsylvania
- University of Pennsylvania School of Nursing - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02778516
The ClinicalTrials.gov registry entry for NCT02778516 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 138-participant average among 13 other ESRD trials with a reported enrollment target (70% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with ESRD appearing as the primary indexed condition, and to 1 intervention - of which Sodium Restriction is the first listed.
NCT02778516 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02778516 about?
NCT02778516 is a clinical study titled "Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT". 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...
What is the current status of trial NCT02778516?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2014-08. Estimated completion is 2016-08.
What conditions does trial NCT02778516 study?
This clinical trial studies the following conditions: ESRD.
What interventions are being tested in trial NCT02778516?
The interventions under investigation include: Sodium Restriction (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02778516?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02778516 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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