Adaptive Nutrition Therapy in Hemodialysis

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05469620
• Other study ID #: DNET_CKD nutrition 1.0
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Renal Dialysis

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