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Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting

Not Applicable
Not yet recruiting
Conditions
Protein-Energy Wasting
Kidney Failure
Hemodialysis
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

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

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
Secondary Outcome Measures
NameTimeMethod
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
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