MedTrace Logo

Dietary Sodium (DS) Intervention to Reduce Volume Overload and Tissue Sodium in Magnetic Resonance Imaging (MRI) for Hemodialysis (HD) Patients

NCT03189758 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-08-03

No results posted yet for this study

Summary

Sodium-adapted magnetic resonance imaging (23Na-MRI) studies have demonstrated that sodium accumulates in certain tissues, including the skin and skeletal muscle, but may be manipulated by lifestyle factors or therapeutic interventions such as a hemodialysis (HD) session. This tissue sodium accumulation is increased with age and in the presence of certain chronic diseases such as renal failure, and may contribute to the development of high blood pressure. It currently not known what the impact of dietary sodium consumption has on tissue sodium in HD patient's and on the subsequent risk of cardiovascular complications either acutely or chronically. The University of Illinois' Biomedical Imaging Center recently completed safety testing on a 23Na-MRI coil that they modified for measuring skin and muscle sodium levels in the lower leg/calf that will be used for assessing the impact of dietary salt restriction on tissue sodium levels.

Conditions

  • Kidney Failure, Chronic
  • Dietary Modification

Interventions

OTHER

Observational Control Diet

Participants will follow their usual or normal diet for 30 days (days 1-30) while under study observation.

OTHER

Controlled Dietary Sodium Restriction

Participants will be provided with all meals and snacks daily, for 30 days (days 31-60). These meals should meet KDQOI guidelines for energy and protein (30-35 kcal/kg \& 1.2 g/kg) as well as low phosphorus, potassium, and sodium. The meals are formulated to less than 600-800 mg sodium each (\<2,000g/day) and will be ordered and delivered through momsmeals.com

Sponsors & Collaborators

  • Renal Research Institute

    collaborator OTHER

  • University of Illinois at Urbana-Champaign

    lead OTHER

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03189758 on ClinicalTrials.gov