Dietary Sodium-Restriction (DIS) and Renal Meals (RM) for Hemodialysis (HD)(DISaRM-HD)

Status unconfirmed · Not applicable

Conditions studied: Kidney Failure, Chronic, Dietary Modification

In brief

Chronic volume overload (VO) is a primary factor responsible for the excessive cardiovascular morbidity and mortality in hemodialysis (HD) patients. VO is caused in part by excessive fluid intake that is secondary to the consumption of a high salt diet. HD patients are often counselled to restrict their dietary sodium intake to help manage thirst and reduce their interdialytic weight gain (IDWG). However, data from recently published investigations demonstrate that dietary counseling alone may be ineffective. The objective of this randomized controlled trial is to determine if short-term feeding of low-sodium meals can "prime" changes in long-term nutrition behavior. It is hypothesized that feeding low-sodium meals for one month will significantly reduce IDWG and related outcomes, and continued dietary counseling and education support for 6 months will result in a sustained reduction in sodium intake upon patient resumption of meal responsibility. HD patients will be recruited and randomized to 2 groups: 1) Low-sodium meal feeding plus dietary counseling; or 2) a weight-list control group that will initially receive dietary counseling alone. IDWG will serve as the primary outcome with fluid volume overload, intradialytic hypotension, cramping, dietary sodium intake, sodium taste sensitivity and preference, and sodium self-efficacy evaluated at 1 and 6 months. This outcomes of this investigation will provide the first data on whether meal provision is an effective tool for dietary modeling and prolonged behavior change in HD patients.

Key facts

Study ID: NCT04991441
Run by: University of Illinois at Urbana-Champaign
People needed: 60
Starts: 2020-11-01
Expected to finish: 2024-03-31
Last updated by the study team: 2021-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willingness to sign informed consent document and age 18 or greater.
High fluid gainer/excessive overloaded defined by: > 3.0 % of estimated-dry weight (EDW)
No upper or lower limb amputations. This criteria is necessary because the BIS device we are using is not able to provide accurate estimates of fluid status in participants with limb amputations.
No pacemakers
Willingness to consume intervention meals provided throughout the study.

You may not qualify if…

not meeting above inclusion criteria 1 - 4

Where it is running

University of Illinois at Urbana-Champaign — Urbana, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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