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This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.
Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Tufts Medical Center
Boston, Massachusetts, United States
Start Date
June 5, 2019
Primary Completion Date
December 31, 2021
Completion Date
December 31, 2021
Last Updated
January 18, 2023
40
ACTUAL participants
Sodium Restricted Meals
OTHER
Control
OTHER
Lead Sponsor
Tufts Medical Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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