Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease

Hemodialysis Complication Clinical Trial

Official title:

Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817799
• Other study ID #: ERC 2022/23
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2023
• Est. completion date: July 10, 2023

Study information

• Verified date: April 2023
• Source: Bahria University
• Contact: Sadia Rehman, MBBS, MPhil
• Phone: 0343-4535510
• Email: dr.sadia89[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: July 10, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Complication
• Kidney Failure, Chronic

Intervention

Drug:
• L-Carnitine 500Mg thrice daily
L-Carnitine 500mg oral thrice daily
• 1g L-Carnitine IV three times a week
1g IV L-Carnitine three times a week

Locations

Country	Name	City	State
Pakistan	Jinnah Post Graduate Medical Center	Karachi	Sindh

Sponsors (4)

Lead Sponsor	Collaborator
Bahria University	Jinnah Postgraduate Medical Centre, Pakistan Navy Station Shifa Hospital, University of Karachi

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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: 10.10 — View 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 201 — View 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. — View 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 — View 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 he — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	L-Carnitine levels in hemodialysis	plasma carnitine will be detected before and after giving intervention (unit µmol/L)	5 months