Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting
- Conditions
- Protein-Energy WastingKidney FailureHemodialysis
- Registration Number
- NCT06569732
- Lead Sponsor
- Universiti Malaysia Sabah
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - on maintenance HD dialysis treatment (thrice weekly and 4-hour per session) for at<br> least three months<br><br> - age 18 - 70 year old<br><br> - diagnosed with protein energy wasting using the malnutrition inflammation score (=<br> 5)<br><br>Exclusion Criteria:<br><br> - a history of poor adherence to HD treatment (frequently miss the HD treatment for<br> more than one session every month)<br><br> - a history of frequent hospitalization (more than once in the past one month)<br><br> - on regular oral nutrition supplements<br><br> - diagnosed with malignancy<br><br> - pregnant or lactating women<br><br> - allergic to study products such as soy milk or milk
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
- Secondary Outcome Measures
Name Time Method Changes from baseline in skeletal muscle mass at 3-month and 6-month;Changes from baseline in body fat mass at 3-month and 6-month;Changes from baseline in energy intake at 3-month and 6-month;Changes from baseline in protein intake at 3-month and 6-month;Changes from baseline in intradialytic weight change at 3-month and 6-month;Changes from baseline in serum albumin at 3-month and 6-month;Changes from baseline in serum phosphorus at 3-month and 6-month;Changes from baseline in serum potassium at 3-month and 6-month;Changes from baseline in handgrip strength at 3-month and 6-month;Cost-Effectiveness Ratio;Acceptability of oral nutrition supplements