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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five months

This trial's timeline: 3 weeks for screening, Varies for treatment, and five months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessing Interdialytic weight gain (IDWG) using bioelectric impedance spectroscopy device (BIS)

Blood Pressure - markers of cardiovascular risk

Secondary study objectives

Dietary Recalls using ASA24

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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