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

NCT03189758 | Unknown

• 1 other identifier: 17530
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic kidney disease; hemodialysis; sodium restriction; MRI

Outcome Measures

Primary Outcomes (2)

• Interdialytic weight gain

  Interdialytic weight from clinic records

  28 days

• Tissue sodium

  MRI detected sodium content in the lower leg (mM)

  28 days

Secondary Outcomes (4)

• Hydration status

  28 days

• Cardiovascular function

  28 days

• Biochemical markers

  28 days

• Gut microbiome (stool sample)

  28 days

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will follow a Observational Control Diet (CON) diet followed by an Controlled Dietary Sodium Restriction (INT) diet.

Other: Observational Control Diet; Other: Controlled Dietary Sodium Restriction

Interventions

Observational Control Diet OTHER

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

Also known as: CON

Intervention

Controlled Dietary Sodium Restriction OTHER

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

Also known as: INT

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to sign informed consent document and age 18 or greater.
• Willingness to consume intervention meals 3 times per day (with provided snacks) for 30 days.

You may not qualify if:

• Individuals with major amputations (i.e. whole limb: foot, ankle, leg, arm)
• Individuals with ferric metal implants or devices in the body (excluded from MRI testing only)
• Claustrophobic individuals (excluded from MRI testing only)
• Individuals that do not otherwise meet MRI screening requirements (mentioned below, excluded from MRI testing only)
• Individuals on HD therapy \<3 days per week or \<3 months
• Currently following a sodium restricted diet approximately \<1,500 mg per day (only excluded from MRI analysis)
• Currently diagnosed GI disorder or disease or infection

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Renal Research Institute: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luis M Perez, BS

CONTACT

7192444805; lmperez2@illinois.edu

Ken Wilund, PhD

CONTACT

2172656755; kwilund@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational control followed by dietary intervention

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: June 19, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

US (1)