Hemodialysis, Kidney Failure, Protein-Energy Wasting
Conditions
Keywords
hemodialysis, protein-energy wasting, kidney failure
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
Interventions
OTHERHomemade oral nutrition supplements
The homemade oral nutrition supplement is made of soy milk, whey protein powder, vegetable oil, and fruit juices
OTHERCommercial oral nutrition supplements
The commercial oral nutrition supplement is kidney-specific oral nutrition supplement that is high in energy and protein, but low in electrolytes and fluid
Sponsors
National Kidney Foundation Malaysia
Universiti Malaysia Sabah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Malnutrition Inflammation Score at 3-month and 6-month | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in body fat mass at 3-month and 6-month | Baseline, 3-month, and 6-month | The body fat mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass |
| Changes from baseline in energy intake at 3-month and 6-month | Baseline, 3-month, and 6-month | The energy intake will be assessed using 24-hour diet recall forms |
| Changes from baseline in protein intake at 3-month and 6-month | Baseline, 3-month, and 6-month | The protein intake will be assessed using 24-hour diet recall forms |
| Changes from baseline in intradialytic weight change at 3-month and 6-month | Baseline, 3-month, and 6-month | The intradialytic weight change will be determined based on difference in post-dialysis and pre-dialysis weight of the next dialysis session |
| Changes from baseline in serum albumin at 3-month and 6-month | Baseline, 3-month, and 6-month | Serum albumin will be obtained from the participants' routine blood test |
| Changes from baseline in skeletal muscle mass at 3-month and 6-month | Baseline, 3-month, and 6-month | The skeletal muscle mass will be measured using a bio-impedance spectroscopy ro determine muscle mass and fat mass |
| Changes from baseline in serum potassium at 3-month and 6-month | Baseline, 3-month, and 6-month | Serum potassium will be obtained from the participants' routine blood test |
| Changes from baseline in handgrip strength at 3-month and 6-month | Baseline, 3-month, and 6-month | Handgrip strength will be measured using a digital hand dynamometer |
| Cost-Effectiveness Ratio | 6-month | The cost-effectiveness ratio will be calculated by dividing the cost of oral nutrition supplements (unit in Malaysia ringgit) for 6 months with the change in malnutrition inflammation score from baseline to 6-month (refer primary outcome 1). In this analysis, there is no minimum or maximum values, but a lower value indicates better cost-effectiveness (lower cost with a greater health benefit). |
| Acceptability of oral nutrition supplements | 6-month | A questionnaire will be used to assess product acceptance using a 5-point Likert scale. The scale ranges from 1 to 5, with higher scores indicating greater acceptance of the product. The questionnaire consists of 5 questions, so the total score ranges from a minimum of 5 to a maximum of 25. |
| Changes from baseline in serum phosphorus at 3-month and 6-month | Baseline, 3-month, and 6-month | Serum phosphorus will be obtained from the participants' routine blood test |
Contacts
Primary ContactBan Hock Khor, PhD
Outcome results
None listed