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Low-Sodium Diet for Kidney Failure (DISaRM-HD Trial)
N/A
Waitlist Available
Led By Kenneth R Wilund, PhD
Research Sponsored by University of Illinois at Urbana-Champaign
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five months
Awards & highlights
DISaRM-HD Trial Summary
This trial is testing whether giving HD patients low-sodium meals for one month, along with dietary counseling, will lead to better long-term nutrition behavior. The primary outcome is reduced interdialytic weight gain (IDWG).
Who is the study for?
This trial is for adults over 18 on hemodialysis for chronic kidney failure, who can consent to the study and are willing to eat provided meals. Participants should not have limb amputations or pacemakers, and must typically gain a lot of fluid between dialysis sessions.Check my eligibility
What is being tested?
The study tests if eating low-sodium meals for one month, followed by dietary counseling for six months, helps patients manage their fluid intake better than just getting dietary advice. The goal is to see if this approach reduces excess fluid in the body.See study design
What are the potential side effects?
Since the intervention involves diet modification rather than medication, side effects may include changes in taste preferences or challenges adapting to new dietary restrictions.
DISaRM-HD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ five months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessing Interdialytic weight gain (IDWG) using bioelectric impedance spectroscopy device (BIS)
Blood Pressure - markers of cardiovascular risk
Secondary outcome measures
Dietary Recalls using ASA24
DISaRM-HD Trial Design
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Participants will be provided with 2 meals and snacks daily, for 30 days (days 1-30) and 1 meal 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
Group II: ControlExperimental Treatment2 Interventions
Participants will follow their usual or normal diet for 5 months (CON) followed by an Controlled Dietary Sodium Restriction (INT) diet for 2 months. During the sodium restricted diet, participants will be provided with 2 meals and snacks daily, for 30 days (Month 5 - days 1-30) and 1 meal and snacks daily, for 30 days (Month 6 - days 31-60). These meals should meet the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (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
Find a Location
Who is running the clinical trial?
Renal Research InstituteOTHER
34 Previous Clinical Trials
79,354 Total Patients Enrolled
1 Trials studying Dietary Modifications
20 Patients Enrolled for Dietary Modifications
University of Illinois at Urbana-ChampaignLead Sponsor
188 Previous Clinical Trials
37,275 Total Patients Enrolled
4 Trials studying Dietary Modifications
197 Patients Enrolled for Dietary Modifications
Kenneth R Wilund, PhDPrincipal InvestigatorUniversity of Illinois at Urbana-Champaign
2 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Dietary Modifications
20 Patients Enrolled for Dietary Modifications
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and willing to sign the consent form.You have gained more than 3.0% of your estimated-dry weight in excess fluid.You have not had an amputation of any part of your arms or legs. This is important because the device we are using cannot accurately measure your fluid levels if you have had an amputation.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dietary Modifications Patient Testimony for trial: Trial Name: NCT04991441 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment of participants currently open for this research project?
"Affirmative. Information accessible on clinicaltrials.gov demonstrates that this experiment, which was originally published on November 1st 2020, is presently recruiting members. Sixty individuals will be accepted from a single medical facility."
Answered by AI
How many individuals are eligible to partake in this experiment?
"Affirmative, the clinicaltrials.gov platform has evidence that this medical trial is actively sourcing participants. This study was initially published on November 1st 2020 and its information was most recently updated on August 4th 2021. Sixty patients are required from a single location to complete the research."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
University of Illinois at Urbana-Champaign
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
As stated, I want to keep the CKD stage 3 from getting worse, plus have liver issues. I don't understand how I got this far. I have just completed a 6-year Eli Lilly Alzheimer drug trial at Washington University, St. louis. Unfortunately, the trial didn't have the results desired.
PatientReceived no prior treatments
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