Clinical Efficacy, Feasibility, and Cost-effectiveness of Homemade Oral Nutrition Supplements on Patients on Hemodialysis With Protein-energy Wasting: a Parallel, Open-labeled, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universiti Malaysia Sabah
- Enrollment
- 40
- Primary Endpoint
- Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
Study Overview
Brief Summary
The goal of this clinical trial is to learn if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis. It will also learn about the cost-effectiveness of homemade oral nutrition supplements. The main questions it aims to answer are:
- Does homemade oral nutrition supplements improve the nutritional status of patients on hemodialysis with protein energy wasting?
- What is the cost-effectiveness of homemade oral nutrition supplements?
Researchers will compare homemade oral nutrition supplements to commercial oral nutrition supplements to see if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis.
Participants will:
- Take homemade or commercial oral nutrition supplements every day for 6 months
- Have assessment of nutritional status performed by researchers every three monthly
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •on maintenance HD dialysis treatment (thrice weekly and 4-hour per session) for at least three months
- •age 18 - 70 year old
- •diagnosed with protein energy wasting using the malnutrition inflammation score (≥ 5)
Exclusion Criteria
- •a history of poor adherence to HD treatment (frequently miss the HD treatment for more than one session every month)
- •a history of frequent hospitalization (more than once in the past one month)
- •on regular oral nutrition supplements
- •diagnosed with malignancy
- •pregnant or lactating women
- •allergic to study products such as soy milk or milk
Arms & Interventions
Homemade oral nutrition supplements
Homemade oral nutrition supplements, 200 ml/day
Intervention: Homemade oral nutrition supplements (Other)
Commercial oral nutrition supplements
Commercial oral nutrition supplements, 200 ml/day
Intervention: Commercial oral nutrition supplements (Other)
Outcomes
Primary Outcomes
Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month
Time Frame: Baseline, 3-month, and 6-month
The Malnutrition Inflammation Score is a composite score used to determine protein energy wasting. It consists of 10 questions, each rated on a scale from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating more severe malnutrition and inflammation. A score of 5 or above suggests the presence of protein-energy wasting.
Secondary Outcomes
- Changes from baseline in skeletal muscle mass at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in body fat mass at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in serum albumin at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in handgrip strength at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Acceptability of oral nutrition supplements(6-month)
- Changes from baseline in energy intake at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in intradialytic weight change at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in protein intake at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Changes from baseline in serum potassium at 3-month and 6-month(Baseline, 3-month, and 6-month)
- Cost-Effectiveness Ratio(6-month)
- Changes from baseline in serum phosphorus at 3-month and 6-month(Baseline, 3-month, and 6-month)
Investigators
Khor Ban Hock
Senior Lecturer
Universiti Malaysia Sabah