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

NCT05817799 | Completed Phase 2

• 1 other identifier: ERC 2022/23
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication

Keywords

Hemodialysis; L-Carnitine; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• L-Carnitine levels in hemodialysis

  plasma carnitine will be detected before and after giving intervention (unit μmol/L)

  5 months

Study Arms (2)

intervention

EXPERIMENTAL

L-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week

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

control

NO INTERVENTION

no intervention given

Interventions

L-Carnitine 500Mg thrice daily DRUG

L-Carnitine 500mg oral thrice daily

intervention

1g L-Carnitine IV three times a week DRUG

1g IV L-Carnitine three times a week

intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The study included people between the ages of 18 and 50 who had had dialysis for more than two years without taking additional antioxidants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahria University: lead
• Pakistan Navy Station Shifa Hospital: collaborator
• Jinnah Postgraduate Medical Centre: collaborator
• University of Karachi: collaborator

Study Sites (1)

Jinnah Post Graduate Medical Center

Karachi, Sindh, 021, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 11856775 BACKGROUND

• 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.

  PMID: 33139659 RESULT

• 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.

  PMID: 33713287 RESULT

• 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.

  PMID: 30353121 RESULT

• 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.

  PMID: 24525835 RESULT

• 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.

  PMID: 34740538 RESULT

• Rehman S, Farhan M, Kumar S, Sarfraz MR, Naveed A, Khan MT, Huq H. Efficacy of Intravenous Versus Oral Administration of Levocarnitine in Maintenance Hemodialysis Patients: A Randomized Controlled Trial Investigating Therapeutic Approaches to Renal Anemia. Health Sci Rep. 2025 Jan 5;8(1):e70297. doi: 10.1002/hsr2.70297. eCollection 2025 Jan.

  PMID: 39763581 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Sadia Rehman

  Bahria University Health Sciences, Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 18, 2023
• Study Start: January 1, 2023
• Primary Completion: July 2, 2023
• Study Completion: July 10, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

PA (1)