Adaptive Nutrition Therapy in Hemodialysis

July 20, 2022 updated by: Hoseok Koo, Inje University

Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients

8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 100-032
        • Inje University Seoul Paik Hospital

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:

  • have been on hemodialysis for over 3 months

Exclusion Criteria:

  • diagnosed with cancer within 5 years

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Receive usual care.
Experimental: Education
Receive nutrition education.
Other: Education
Leaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links.
Experimental: Meal
Receive meal kit.
Dietary supplement: Meal
Either a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day.
Experimental: Education and Meal
Receive both nutrition education and meal kit.
Other: Education
Leaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links.
Dietary supplement: Meal
Either a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potassium
Time Frame: 4 weeks
Serum potassium level measured from routine blood test.
4 weeks
Phosphate
Time Frame: 4 weeks
Serum phosphate level measured from routine blood test.
4 weeks
Malnutrition
Time Frame: 8 weeks
10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 8 weeks
21-item depression score measured with Korean-Beck Depression Inventory. Scores rnage from 0 to 63, higher value corresponding to worse outcome (severe depression).
8 weeks
Self-Efficacy
Time Frame: 8 weeks
10-item Self-Efficacy score for hemodialysis patients. Scores range from 10 to 40, higher values corresponding to better outcome (higher self-efficacy).
8 weeks

Collaborators and Investigators

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

Sponsor

Inje University

Collaborators

Korea University Guro Hospital
Seoul National University
Hallym University Kangnam Sacred Heart Hospital
KangWon National University Hospital
Myongji Hospital
Korea University Ansan Hospital
Korea Data Agency
Eatmapl
Daejeon Eulji Medical Center

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)

October 6, 2021

Primary Completion (Actual)

December 26, 2021

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DNET_CKD nutrition 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Renal Dialysis

Clinical Trials on Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe