Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000335695
Ethics application status
Approved
Date submitted
9/11/2022
Date registered
31/03/2023
Date last updated
31/03/2023
Date data sharing statement initially provided
31/03/2023
Date results information initially provided
31/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Immunonutrition Supplements on Pressure Ulcers and Malnutrition Status among Spinal Cord Injury Patients Under Rehabilitation
Scientific title
The Effect of Immunonutrition Supplements on Pressure Ulcers and Malnutrition Status among Spinal Cord Injury Patients Under Rehabilitation
Secondary ID [1] 308374 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure ulcers 328170 0
Spinal cord injury 328171 0
Condition category
Condition code
Skin 325222 325222 0 0
Other skin conditions
Diet and Nutrition 325935 325935 0 0
Other diet and nutrition disorders
Neurological 326293 326293 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324826 0
Treatment: Other
Intervention code [2] 325400 0
Lifestyle
Comparator / control treatment
Participants in the control group received individual dietary counselling on high-calorie and high-protein diets at baseline, according to personal recommendation (Ministry of Health Malaysia, 2014). The control group was given dietary advice for one hour during baseline and follow-up at 14 days. 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).
Control group
Active

Outcomes
Primary outcome [1] 333067 0
Wound healing [Pressure Ulcer Scale for Healing (PUSH) score]
Timepoint [1] 333067 0
Baseline (Primary timepoint), days 14 (post-intervention commencement) and 56 (primary endpoint)
Primary outcome [2] 333068 0
Anthropometric measurements, e.g. Weight was measured with minimal clothing without shoes using a calibrated chair scale SECA Electronic FZ Tropical Resources Model to the nearest 0.1 kg, which was accessible for those participants with difficulty standing straight. The height of tetraplegia and paraplegia patients was measured by arm-span measurements using Lufkin measuring tape (Apex Tool Group, UK). The standard formula used for height estimation as suggested by Mitchell and Lipschitz (1982). The Body Mass Index (BMI, kg/m2) was calculated as the body weight in kilograms divided by the squared standing height in meters.
Timepoint [2] 333068 0
Baseline (Primary timepoint), days 14 (post-intervention commencement) and 56 (primary endpoint)
Primary outcome [3] 333802 0
Patient-Generated Subjective Global Assessment (PG-SGA)
Timepoint [3] 333802 0
Baseline (Primary timepoint), days 14 (post-intervention commencement) and 56 (primary endpoint)
Secondary outcome [1] 415705 0
A total of 10 ml peripheral fasting venous blood samples were drawn by a trained phlebotomist and analysed for C-reactive protein, albumin and haemoglobin at the medical laboratory of the hospital.
Timepoint [1] 415705 0
Baseline, days 14 (post-intervention commencement) and 56
Secondary outcome [2] 418346 0
24-hour diet recall
Timepoint [2] 418346 0
Baseline, days 14 (post-intervention commencement) and 56

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Patients with full nasogastric tube feeding
ii) Patients with pressure sores due to diabetic ulcers and trauma due to infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A total of 18 participants who met the criteria were selected by simple sampling and allocated to the intervention group and the control groups using the Random Allocation Software Version 1.0 May 2004. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Random Allocation Software Version 1.0 May 2004).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis was performed using Statistical Package for Social Study version 23.0 (SPSS Inc. Chicago, II, USA). The data's normality was analysed using the Shapiro-Wilk test, with p>0.05 indicating normal distribution. The mean differences of the baseline data between the intervention and control group were analysed using the Independent-t-test for continuous parameters, whilst chi-square test was for the categorical variables. The intervention effects were analysed using a two-way repeated measure analysis of variance (ANOVA) that was adjusted for confounding variables. The percentage of mean change from baseline to 56 days was calculated and presented as a line chart. The percentage of mean change for each participant was calculated as follows: [score at 56 days – score of baseline)/score of baseline] × 100%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/04/2019
Date of last participant enrolment
Anticipated
Actual
17/06/2019
Date of last data collection
Anticipated
Actual
12/08/2019
Sample size
Target
20
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 25115 0
Malaysia
State/province [1] 25115 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 312620 0
Commercial sector/Industry
Name [1] 312620 0
Asian Medical Nutrition Group
Country [1] 312620 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 314876 0
Commercial sector/Industry
Name [1] 314876 0
Kumpulan Perubatan Nutrisi Asia
Address [1] 314876 0
Subang Jaya, Malaysia
Country [1] 314876 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311938 0
Medical Research Ethics Committee Universiti Kebangsaan Malaysia
Ethics committee address [1] 311938 0
Secretariat of Research and Innovation
Faculty of Medicine UKM
2nd Floor, Educational Block
Jalan Yaacob Latif, Bandar Tun Razak
56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
Ethics committee country [1] 311938 0
Malaysia
Date submitted for ethics approval [1] 311938 0
01/02/2019
Approval date [1] 311938 0
17/04/2019
Ethics approval number [1] 311938 0
NN-2019-084

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122906 0
Prof Suzana Shahar
Address 122906 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 122906 0
Malaysia
Phone 122906 0
+60392897602
Fax 122906 0
+60326914304
Email 122906 0
Suzana.shahar@ukm.edu.my
Contact person for public queries
Name 122907 0
Prof Suzana Shahar
Address 122907 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 122907 0
Malaysia
Phone 122907 0
+60392897602
Fax 122907 0
+60326914304
Email 122907 0
Suzana.shahar@ukm.edu.my
Contact person for scientific queries
Name 122908 0
Prof Suzana Shahar
Address 122908 0
Centre for Healthy Aging and Wellness
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 122908 0
Malaysia
Phone 122908 0
+60392897602
Fax 122908 0
+60326914304
Email 122908 0
Suzana.shahar@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.