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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05469620
Other study ID # DNET_CKD nutrition 1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 6, 2021
Est. completion date February 28, 2022

Study information

Verified date July 2022
Source Inje University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date February 28, 2022
Est. primary completion date December 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - have been on hemodialysis for over 3 months Exclusion Criteria: - diagnosed with cancer within 5 years

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Inje University Seoul Paik Hospital Seoul

Sponsors (10)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Potassium Serum potassium level measured from routine blood test. 4 weeks
Primary Phosphate Serum phosphate level measured from routine blood test. 4 weeks
Primary Malnutrition 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 Depression 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
Secondary Self-Efficacy 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
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