CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Mealsdietary
Likely dose
Not stated in record
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Search/NCT02917278
NCT02917278N/ACompleted

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

Purdue University·interventional·Posted Sep 28, 2016·Updated Oct 19, 2021

In Brief

A clinical study evaluating Meals for End-Stage Renal Disease and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 28, 2016
Enrollment StartFeb 1, 2016
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.8 years ago

Interventions

Mealsdietary

High Protein renal-specific meals