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Adaptive Nutrition Therapy in Hemodialysis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05469620
Enrollment
175
Registered
2022-07-22
Start date
2021-10-06
Completion date
2022-02-28
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

nutrition

Brief summary

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

Interventions

DIETARY_SUPPLEMENTMeal

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.

OTHEREducation

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

2 by 2 factorial design, consisting of nutrition education and meal kit prescription.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* have been on hemodialysis for over 3 months

Exclusion criteria

* diagnosed with cancer within 5 years

Design outcomes

Primary

MeasureTime frameDescription
Potassium4 weeksSerum potassium level measured from routine blood test.
Phosphate4 weeksSerum phosphate level measured from routine blood test.
Malnutrition8 weeks10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition)

Secondary

MeasureTime frameDescription
Depression8 weeks21-item depression score measured with Korean-Beck Depression Inventory. Scores rnage from 0 to 63, higher value corresponding to worse outcome (severe depression).
Self-Efficacy8 weeks10-item Self-Efficacy score for hemodialysis patients. Scores range from 10 to 40, higher values corresponding to better outcome (higher self-efficacy).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026