N/A
Completed N=179
Intervention to Reduce Dietary Sodium in Hemodialysis
Renal Dialysis
Source: ClinicalTrials.gov NCT01125202 ↗
Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Time Specific Interdialytic Weight Gain (Baseline) — 1.2; 1.2 kg/day
Summary
The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Specific Interdialytic Weight Gain (Baseline) |
1.2; 1.2 | — |
| PRIMARY Time Specific Interdialytic Weight Gain (8 Weeks) |
1.1; 1.2 | — |
| PRIMARY Time Specific Interdialytic Weight Gain (12 Weeks) |
1.2; 1.2 | — |
| PRIMARY Time Specific Interdialytic Weight Gain (16 Weeks) |
1.1; 1.2 | — |
| PRIMARY Time Specific Dietary Sodium Intake (Baseline) |
2555; 2298 | — |
| PRIMARY Time Specific Dietary Sodium Intake (8 Weeks) |
2316; 2573 | — |
| PRIMARY Time Specific Dietary Sodium Intake (16 Weeks) |
2371; 2447 | — |
| PRIMARY Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) |
-71; 237 | — |
| PRIMARY Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) |
59; 131 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals with end stage renal disease (ESRD) who are 18 years of age or older,
- Individuals who are literate,
- Community-dwelling adults who have been receiving maintenance dialysis for at least 3 months.
Exclusion Criteria
- Individuals who cannot read or write,
- Individuals who do not speak English,
- Individuals who plan to move out of the area or change dialysis centers within the next 6 months,
- Individuals who have a life expectancy of less than 12 months,
- Individuals who are scheduled for a living donor transplant,
- Individuals who cannot see the PDA screen or use the stylus to make food selections from the PDA screen, or
- Individuals who live in an institutional setting in which they would have limited control over their dietary intake.
Data sourced from ClinicalTrials.gov (NCT01125202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.