Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
Primary Purpose
Hemodialysis Complication
Status
Recruiting
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
L-Carnitine 500Mg thrice daily
1g L-Carnitine IV three times a week
Sponsored by
About this trial
This is an interventional supportive care trial for Hemodialysis Complication focused on measuring Hemodialysis, L-Carnitine, chronic kidney disease
Eligibility Criteria
Inclusion Criteria: • Individuals of either sex (male and female). The study included people between the ages of 18 and 50 who had had dialysis for more than two years without taking additional antioxidants. Exclusion Criteria: • Individuals with any other chronic ailment, such as cancer or tuberculosis. Patients with acute renal failure who are receiving hemodialysis. All subjects who refused to take part in the investigation.
Sites / Locations
- Jinnah Post Graduate Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
control
Arm Description
L-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week
no intervention given
Outcomes
Primary Outcome Measures
L-Carnitine levels in hemodialysis
plasma carnitine will be detected before and after giving intervention (unit μmol/L)
Secondary Outcome Measures
Full Information
NCT ID
NCT05817799
First Posted
March 24, 2023
Last Updated
April 5, 2023
Sponsor
Bahria University
Collaborators
Pakistan Navy Station Shifa Hospital, Jinnah Postgraduate Medical Centre, University of Karachi
1. Study Identification
Unique Protocol Identification Number
NCT05817799
Brief Title
Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
Official Title
Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 2, 2023 (Anticipated)
Study Completion Date
July 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahria University
Collaborators
Pakistan Navy Station Shifa Hospital, Jinnah Postgraduate Medical Centre, University of Karachi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
OBJECTIVES
To assess the levels of plasma carnitine in controls and hemodialysis patients.
To give supplementary L-carnitine to study subjects for a duration of 5months.
To compare the values of plasma carnitine before and after L carnitine supplementation.
To assess the role of carnitine supplementation on biochemical and clinical parameters.
Detailed Description
.ABSTRACT INTRODUCTION Dialysis therapy can cause a decrease in both free carnitine and plasma acyl carnitines after only six months of dialysis treatment. A positive correlation between AC/FC ratio and months on HD therapy has been reported. We investigate in this study the role of oral L-carnitine supplementation on anemia, blood pressure, cardiac dysfunction and muscle cramps in hemodialysis patients.
OBJECTIVES
To assess the levels of plasma carnitine in controls and hemodialysis patients.
To give supplementary L-carnitine to study subjects for a duration of 5months.
To compare the values of plasma carnitine before and after L carnitine supplementation.
To assess the role of carnitine supplementation on biochemical and clinical parameters.
STUDY DESIGN AND SETTING: It will be a case-control study, which will be conducted in the Department of Biochemistry, University of Karachi in collaboration with Nephrology ward of JPMC, Karachi in a period of one year after approval of synopsis.
METHOD: Total 120 subjects will be included in this study which will be divided into two groups. Group A will comprise of 60 subjects of Chronic renal failure who will be the control group. Group B will comprise of 60 subjects who will be on hemodialysis for more than 1 year. Blood samples will be taken after informed consent. Group B subjects will be given L-Carnitine supplementation for five months under strict monitoring. Physical, biochemical and clinical parameters of group B subjects will be compared before and after supplementation.
RESULTS: Data will be analyzed using SPSS version 21. Results will be shared after completion of research.
CONCLUSION: conclusion will be shared after completion of research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication
Keywords
Hemodialysis, L-Carnitine, chronic kidney disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Subjects of group B oral intervention group were given oral L-carnitine supplementation in the form of L-Carnitine tablets 500 mg thrice daily under strict monitoring for 5 months. The vitals were monitored daily during the course of supplementation.
Subjects of group B intravenous group were given Intra venous L-Carnitine as a dose of 20mg/kg IV bolus infused over 2-3 minutes, administered into intra venous line after every hemodialysis session ( thrice a week) for 5 months.
Complete general physical examination was done on every dialysis session. Patients were strictly monitored for the development of any signs of distress during the course of supplementation the drug. The patients and their attendants were educated about monitoring the vitals at home daily and to inform nephrologist immediately in case of any signs of allergy or distress. The supplementation was given after obtaining ethical approval and informed consent and under direct supervision of a Nephrologist.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
L-Carnitine 500mg thrice daily
1g L-Carnitine IV three times a week
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention given
Intervention Type
Drug
Intervention Name(s)
L-Carnitine 500Mg thrice daily
Intervention Description
L-Carnitine 500mg oral thrice daily
Intervention Type
Drug
Intervention Name(s)
1g L-Carnitine IV three times a week
Intervention Description
1g IV L-Carnitine three times a week
Primary Outcome Measure Information:
Title
L-Carnitine levels in hemodialysis
Description
plasma carnitine will be detected before and after giving intervention (unit μmol/L)
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Individuals of either sex (male and female).
The study included people between the ages of 18 and 50 who had had dialysis for more than two years without taking additional antioxidants.
Exclusion Criteria:
• Individuals with any other chronic ailment, such as cancer or tuberculosis.
Patients with acute renal failure who are receiving hemodialysis.
All subjects who refused to take part in the investigation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sadia Rehman, MBBS, MPhil
Phone
0343-4535510
Email
dr.sadia89@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadia Rehman
Organizational Affiliation
Bahria University Health Sciences, Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Post Graduate Medical Center
City
Karachi
State/Province
Sindh
ZIP/Postal Code
021
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadia Rehman, MBBS,MPhil
Phone
+923434535510
Email
dr.sadia89@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
11856775
Citation
Hurot JM, Cucherat M, Haugh M, Fouque D. Effects of L-carnitine supplementation in maintenance hemodialysis patients: a systematic review. J Am Soc Nephrol. 2002 Mar;13(3):708-714. doi: 10.1681/ASN.V133708.
Results Reference
background
PubMed Identifier
33139659
Citation
Kuwasawa-Iwasaki M, Io H, Muto M, Ichikawa S, Wakabayashi K, Kanda R, Nakata J, Nohara N, Tomino Y, Suzuki Y. Effects of L-Carnitine Supplementation in Patients Receiving Hemodialysis or Peritoneal Dialysis. Nutrients. 2020 Nov 1;12(11):3371. doi: 10.3390/nu12113371.
Results Reference
result
PubMed Identifier
33713287
Citation
Zhu Y, Xue C, Ou J, Xie Z, Deng J. Effect of L-carnitine supplementation on renal anemia in patients on hemodialysis: a meta-analysis. Int Urol Nephrol. 2021 Oct;53(10):2149-2158. doi: 10.1007/s11255-021-02835-5. Epub 2021 Mar 13.
Results Reference
result
PubMed Identifier
30353121
Citation
Maruyama T, Maruyama N, Higuchi T, Nagura C, Takashima H, Kitai M, Utsunomiya K, Tei R, Furukawa T, Yamazaki T, Okawa E, Ando H, Kikuchi F, Abe M. Efficacy of L-carnitine supplementation for improving lean body mass and physical function in patients on hemodialysis: a randomized controlled trial. Eur J Clin Nutr. 2019 Feb;73(2):293-301. doi: 10.1038/s41430-018-0348-y. Epub 2018 Oct 23.
Results Reference
result
PubMed Identifier
24525835
Citation
Huang H, Song L, Zhang H, Zhang H, Zhang J, Zhao W. Influence of L-carnitine supplementation on serum lipid profile in hemodialysis patients: a systematic review and meta-analysis. Kidney Blood Press Res. 2013;38(1):31-41. doi: 10.1159/000355751. Epub 2014 Feb 6.
Results Reference
result
PubMed Identifier
34740538
Citation
Hamedi-Kalajahi F, Imani H, Mojtahedi S, Shabbidar S. Effect of L-Carnitine Supplementation on Inflammatory Markers and Serum Glucose in Hemodialysis Children: A Randomized, Placebo-Controlled Clinical Trial. J Ren Nutr. 2022 Mar;32(2):144-151. doi: 10.1053/j.jrn.2021.03.009. Epub 2021 Nov 3.
Results Reference
result
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Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
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