Adaptive Nutrition Therapy in Hemodialysis

Not Applicable

Completed

• Conditions: Renal Dialysis

• Registration Number: NCT05469620
• Lead Sponsor: Inje University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-06
• Primary Completion: 2021-12-26
• Study Completion: 2022-02-28
• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• have been on hemodialysis for over 3 months

Exclusion Criteria

• diagnosed with cancer within 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Malnutrition	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)
Potassium	4 weeks	Serum potassium level measured from routine blood test.
Phosphate	4 weeks	Serum phosphate level measured from routine blood test.

Secondary Outcome Measures

Name	Time	Method
Depression	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).
Self-Efficacy	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).

Trial Locations

Locations (1)

Inje University Seoul Paik Hospital; 🇰🇷 Seoul, Korea, Republic of