Renal Dialysis Clinical Trial
Official title:
Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients
Verified date | July 2022 |
Source | Inje University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Inje University Seoul Paik Hospital | Seoul |
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 |
Korea, Republic of,
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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