AzTrials
AzTrials

Hemodialysis ComplicationPhase 2/3NCT05817799

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

A Phase 2/3 study testing L-Carnitine 500Mg thrice daily and 1g L-Carnitine IV three times a week in people with Hemodialysis Complication, run by Bahria University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Hemodialysis Complication
What is being tested?
L-Carnitine 500Mg thrice daily and 1g L-Carnitine IV three times a week
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 sitePakistan
Study dates
1 Jan 2023to 10 Jul 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Jinnah Post Graduate Medical Center

    Karachi, Sindh, 021

Other trials in Pakistan

About this study

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.

Being tested
L-Carnitine 500Mg thrice daily, 1g L-Carnitine IV three times a week
Keywords
Hemodialysis, L-Carnitine, chronic kidney disease
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-Carnitine 500Mg thrice dailyDrug

    L-Carnitine 500mg oral thrice daily

  • 1g L-Carnitine IV three times a weekDrug

    1g IV L-Carnitine three times a week

Study groups in NCT05817799
Study groupRoleWhat they receive
interventionExperimentalL-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week
Receives: Drug: L-Carnitine 500Mg thrice daily; Drug: 1g L-Carnitine IV three times a week
controlNo interventionno intervention given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. L-Carnitine levels in hemodialysis

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

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start1 Jan 2023
  3. Primary completion2 Jul 2023
  4. Study completion10 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
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)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05817799
Sponsor's protocol ID
ERC 2022/23
Status last verified
Aug 2024
First submitted
24 Mar 2023
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

  • 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.

    PubMed 39763581

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing L-Carnitine 500Mg thrice daily and 1g L-Carnitine IV three times a week in people with Hemodialysis Complication, run by Bahria University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

L-Carnitine levels in hemodialysis (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05817799, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in