Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT
ESRD
About this trial
This is an interventional prevention trial for ESRD
Eligibility Criteria
Inclusion Criteria:
- persons ≥ 21 years of age
- who have the ability to read and write,
- who are undergoing maintenance HD
- who are on therapy for at least 3 months.
Exclusion Criteria:
- unable to read or write
- non-English speaking
- intend to move out of the area or change HD centers within 6 months
- have terminal illness or life expectancy of less than 12 months,
- plan to receive a living donor transplant in the study period, have cognitive impairment
- are unable to provide informed consent
- have heart Failure Class III or IV
- have an internal defibrillator or pacemaker, and/or are pregnant.
Sites / Locations
- University of Pennsylvania School of Nursing
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
No Intervention
Sodium Restriction 1500mg Group
Sodium Restriction 2400mg Group
Control Group
During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.
During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.
During the intervention phase of the study, participants will consume iso-caloric diets provided by the CTRC Nutrition Services Metabolic Kitchen at the UPHS. Diets will differ only in sodium content. To ensure accurate calculation of calorie and dietary sodium content for each individual, sodium content from all uneaten foods will be deducted from total daily dietary sodium intake. Total sodium intake will be calculated by CTRC Nutrition Staff and recorded on the data collection sheet after each meal and used in final analyses.