Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting (HOMES-HD)

Universiti Malaysia Sabah

Status: Not yet enrolling

Conditions: Kidney Failure; Hemodialysis; Protein-Energy Wasting

Treatments: Other: Commercial oral nutrition supplements; Other: Homemade oral nutrition supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT06569732

LPS2409

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Homemade oral nutrition supplements

Experimental group

Description:

Homemade oral nutrition supplements, 200 ml/day

Treatment:

Other: Homemade oral nutrition supplements

Commercial oral nutrition supplements

Active Comparator group

Description:

Commercial oral nutrition supplements, 200 ml/day

Treatment:

Other: Commercial oral nutrition supplements