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CompletedNCT05817799Updated Aug 9, 2024

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

A Phase 2/3 interventional study of L-Carnitine 500Mg thrice daily and 1g L-Carnitine IV three times a week in Hemodialysis Complication, sponsored by Bahria University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Bahria University · Phase 2/3, Interventional, and Supportive care

Phase
Phase 2/3
Study type
Interventional
Enrollment
83
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Hemodialysis Complication

Keywords

  • Hemodialysis
  • L-Carnitine
  • chronic kidney disease
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 83 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Bahria University is the lead sponsor of 35 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    intervention

    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

  • No intervention
    control

    no intervention given

Interventions

  • DrugL-Carnitine 500Mg thrice daily

    L-Carnitine 500mg oral thrice daily

  • Drug1g L-Carnitine IV three times a week

    1g IV L-Carnitine three times a week

06

What researchers measure

Primary outcomes

  1. L-Carnitine levels in hemodialysis

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

    Time frame: 5 months

07

Study locations

1 site
  • Jinnah Post Graduate Medical Center
    Karachi, Sindh 021, Pakistan
08

References and documents

Publications

  • 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. PubMed 11856775 ↗
  • 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. PubMed 33139659 ↗
  • 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. PubMed 33713287 ↗
  • 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. PubMed 30353121 ↗
  • 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. PubMed 24525835 ↗
  • 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. PubMed 34740538 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05817799
Lead sponsor
Bahria University
Collaborators
Pakistan Navy Station Shifa Hospital, Jinnah Postgraduate Medical Centre, University of Karachi
Responsible party
Sadia Rehman (Senior Assistant Professor, Bahria University) — Principal investigator
First posted
Apr 18, 2023
Start date
Jan 1, 2023
Primary completion
Jul 2, 2023
Completion
Jul 10, 2023
Last update
Aug 9, 2024

Study contacts

Sadia Rehman
principal investigator · Bahria University Health Sciences, Karachi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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