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The Effect of Immunonutrition Supplements on Pressure Ulcers and Malnutrition Status among Spinal Cord Injury Patients Under Rehabilitation

The Effect of Immunonutrition Supplements on Pressure Ulcers and Malnutrition Status among Spinal Cord Injury Patients Under Rehabilitation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000335695
Enrollment
18
Registered
2023-03-31
Start date
2019-04-22
Completion date
2019-06-17
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Introduction: Pressure ulcers (PU) are highly prevalent among spinal cord injury (SCI) patients and might interfere with rehabilitation and outcomes. Thus, this study aims to determine the efficacy of immunonutrition supplementation in improving PU healing, nutritional status and biochemical parameters among malnourished SCI patients under rehabilitation. Methods: This is a randomized controlled trial (RCT) involving a total of 20 SCI outpatients (aged 18-75 years) with pressure ulcer stages II, III, and IV. The eligible patients were randomized to receive either immunonutrition (arginine, glutamine, and fish oil) supplementation, 250ml two times per day together with dietary advice, or dietary advice alone for 56 days. Wound healing [Pressure Ulcer Scale for Healing (PUSH) score], nutritional status [anthropometric measurements and Patient-Generated Subjective Global Assessment (PG-SGA), 24-hour diet recall], and biochemical profiles (albumin, haemoglobin and C-reactive protein (CRP)) were assessed at baseline, day 14 and 56. This study hypothesises that immunonutrition supplements can improve wound healing, nutritional status and increased nutrient intakes among SCI patients with pressure ulcers during the rehabilitation phase.

Interventions

A total of 18 outpatients (aged 18-75 years) with grade II, III, and IV pressure sores, 15% had malnutrition, and 75% were at risk of malnutrition, were screened and recruited. The intervention group received 250 ml immunonutrition supplements (3.12 g arginine, 1.56 g glutamine, 1.4 g fish oil, 3.5 g medium-chain triglycerides (MCT), and 83 g vitamin C per serving) twice daily, along with 1-hour advice on a high-calorie diet and a high protein diet for 56 days. The solution was prepared by mixin

A total of 18 outpatients (aged 18-75 years) with grade II, III, and IV pressure sores, 15% had malnutrition, and 75% were at risk of malnutrition, were screened and recruited. The intervention group received 250 ml immunonutrition supplements (3.12 g arginine, 1.56 g glutamine, 1.4 g fish oil, 3.5 g medium-chain triglycerides (MCT), and 83 g vitamin C per serving) twice daily, along with 1-hour advice on a high-calorie diet and a high protein diet for 56 days. The solution was prepared by mixing 60 grams of the study product with 250 ml of water at room temperature until it was dissolved and consumed orally. The patients started the consumption of the supplements a day after the consultation. The control group was given dietary advice for one hour for two sessions; during baseline (before starting the supplement) and 14 days later. The dietary guidelines were also provided to the control group (Ministry of Health, 2014). The calorie and protein for each patient are calculated according to their needs and requirements. They are also advised to consume a lot of fruits and vegetables to meet their vitamin and mineral needs. A dietician will deliver a face-to-face dietary consultation for each participant (one-to-one) with a minimum of five years of experience at the outpatient clinic (Rehabilitation Clinic, Pusat Perubatan UKM). The compliance was assessed by instructing the participants to record the intake of the product in the Supplement Intake Compliance Form on a daily basis. The packaging of the product was kept after consumption, or the participants must return the product if they had forgotten or were reluctant to take the supplements during the follow-up visits. The investigator also made a weekly phone call to each participant to ensure adherence and monitor compliance.

Sponsors

Universiti Kebangsaan Malaysia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria were spinal cord injury patients with an outpatient appointment at the clinic with pressure ulcers stage II, III and IV (Black et al. 2007), malnutrition or at-risk of malnutrition, not diabetic, and able to communicate.

Exclusion criteria

i) Patients with full nasogastric tube feeding ii) Patients with pressure sores due to diabetic ulcers and trauma due to infection.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026