Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000504516
Ethics application status
Approved
Date submitted
21/11/2023
Date registered
24/04/2024
Date last updated
24/04/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of carnitine supplementation on mental and physical well being of patients on haemodialysis for end stage kidney disease
Scientific title
Effect of levocarnitine supplementation on quality of life amongst patients on maintenance haemodialysis for end stage renal disease
Secondary ID [1] 311008 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal disease 332115 0
Condition category
Condition code
Renal and Urogenital 328845 328845 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Levocarnitine 1 gram (diluted to 20ml with normal saline) will be administered into the venous port of dialysis circuit/ tubing, slowly over 3- 5 minutes within the first 15 minutes of starting each haemodialysis session. This would be done by the dialysis technician responsible for patient care during that particular haemodialysis session.
Levocarnitine would be administered two times each week for a total of 2 months
Intervention code [1] 327446 0
Treatment: Drugs
Comparator / control treatment
20ml normal saline will be administered into the venous port of dialysis circuit/ tubing, slowly over 3- 5 minutes within the first 15 minutes of starting each haemodialysis session. This would be done by the dialysis technician responsible for patient care during that particular haemodialysis session. Normal Saline would be administered two times each week for a total of 2 months
Control group
Placebo

Outcomes
Primary outcome [1] 336641 0
Physical well-being
Timepoint [1] 336641 0
Baseline, and at 8 weeks post commencement of treatment
Primary outcome [2] 336642 0
Emotional well-being
Timepoint [2] 336642 0
Baseline, and at 8 weeks pos commencement of treatment
Secondary outcome [1] 429135 0
Side effects to treatment (abdominal cramps, diarrhoea, vomiting, abnormal skin odour, seizures, palpitations)
Timepoint [1] 429135 0
Baseline, and at 8 weeks post commencement of treatment

Eligibility
Key inclusion criteria
(1) Patients diagnosed with end-stage renal disease undergoing maintenance haemodialysis two times a week for at least 3 months.
(2) Patients willing to participate and provide informed consent.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patients with a history of allergic reactions to levocarnitine.
(2) Patients who have received L-carnitine therapy in previous 3 months.
(3) Patients with cognitive difficulties who are unable to comprehend questions on the SF-36 questionnaire
(4) Limited mobility

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 doctor at the trial site would be holding the allocation list. He would be contacted every time a patient needs to be allotted to a particular treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 25979 0
Pakistan
State/province [1] 25979 0
Punjab

Funding & Sponsors
Funding source category [1] 315851 0
Self funded/Unfunded
Name [1] 315851 0
Dr. Obaid Ur Rehman, Pak Emirates Military Hospital Rawalpindi Pakistan
Country [1] 315851 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Obaid Ur Rehman, Pak Emirates Military Hospital Rawalpindi Pakistan
Address
Pak Emirates Military Hospital , The Mall, Rawalpindi 46000
Country
Pakistan
Secondary sponsor category [1] 317985 0
None
Name [1] 317985 0
Address [1] 317985 0
Country [1] 317985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314191 0
Ethical Review Committee of Pak Emirates Military Hospital Rawalpindi Pakistan
Ethics committee address [1] 314191 0
Pak Emirates Military Hospital , The Mall, Rawalpindi, Post Code 46000, Punjab, Pakistan
Ethics committee country [1] 314191 0
Pakistan
Date submitted for ethics approval [1] 314191 0
01/11/2023
Approval date [1] 314191 0
04/12/2023
Ethics approval number [1] 314191 0

Summary
Brief summary
Patients of End Stage renal disease on maintenance haemodialysis will be divided into two groups. The test group will be given levocarnitine injection after each session of haemodialysis while the control group will be given placebo. Patients' wellness as per SF 36 questionnaire will be compared before and after levocarnitine treatment for two months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130734 0
Dr Obaid Ur Rahman
Address 130734 0
Pak Emirates Military Hospital , The Mall, Rawalpindi 46000
Country 130734 0
Pakistan
Phone 130734 0
+923365025270
Fax 130734 0
Email 130734 0
obaids282@gmail.com
Contact person for public queries
Name 130735 0
Dr Obaid Ur Rahman
Address 130735 0
Pak Emirates Military Hospital , The Mall, Rawalpindi 46000
Country 130735 0
Pakistan
Phone 130735 0
+923365025270
Fax 130735 0
Email 130735 0
obaids282@gmail.com
Contact person for scientific queries
Name 130736 0
Dr Obaid Ur Rahman
Address 130736 0
Pak Emirates Military Hospital , The Mall, Rawalpindi 46000
Country 130736 0
Pakistan
Phone 130736 0
+923365025270
Fax 130736 0
Email 130736 0
obaids282@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
The data would be deposited in Harvard Dataverse, and would be freely downloadable.
Interim data requests can be forwarded to obaids282@gmail.com


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.