Pilot Study of Nutrition in Maintenance Hemodialysis Patients

September 23, 2021 updated by: Kathleen Hill Gallant, Purdue University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women
  • Any race
  • Age 18 years or older
  • Maintenance hemodialysis patients

Exclusion Criteria:

• Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meals
High-protein renal-specific meals
Dietary supplement: Meals
High Protein renal-specific meals
No Intervention: Control
No Meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotensive Event Frequency
Time Frame: 9 weeks
frequency of hypotensive events that require intervention during dialysis
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure (mm Hg)
Time Frame: 9 weeks
Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.
9 weeks
Serum Albumin
Time Frame: 9 weeks
9 weeks
Blood Urea Nitrogen
Time Frame: 9 weeks
9 weeks
Serum Creatinine
Time Frame: 9 weeks
9 weeks
Blood Glucose
Time Frame: 9 weeks
9 weeks
Serum Adjusted Calcium
Time Frame: 9 weeks
9 weeks
Serum Sodium
Time Frame: 9 weeks
9 weeks
Serum Phosphate
Time Frame: 9 weeks
9 weeks
Serum Chloride
Time Frame: 9 weeks
9 weeks
Serum CO2
Time Frame: 9 weeks
9 weeks
Serum Pre-albumin
Time Frame: 9 weeks
9 weeks
Dialysis Absences
Time Frame: 9 weeks
Absences out of 25 sessions
9 weeks
Interdialytic Weight Gain
Time Frame: 9 weeks
9 weeks
Vitality Score
Time Frame: 9 weeks
Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
9 weeks
Sleep Problems Index
Time Frame: 9 weeks
Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.
9 weeks
Hunger Rating
Time Frame: 9 weeks
Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Investigators

  • Principal Investigator: Kathleen M Hill Gallant, PhD, Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1510016673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participate data is available to other researchers upon reasonable request.

Study Data/Documents

  1. Meeting abstract
    Information comments: Abstract presented as a poster at the ASN Kidney Week 2016 (TH-PO762)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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