L-carnitine Supplementation in Rheumatoid Arthritis Patients

January 4, 2025 updated by: German University in Cairo

Effect of L-carnitine Supplementation on Disease Activity in Rheumatoid Arthritis Patients

This study aims to evaluate the effect of l-carnitine as add- on therapy for improving the outcome in rheumatoid arthritis patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is an inflammatory autoimmune disease that affects joints of hand, wrist and foot. Its epidemiology is more pronounced in female to male in ratio 3:1 . Etiology of the disease is related to genetics and environmental factors that lead to formation of epitopes initiating autoimmune response . It is characterized by symmetrical polyarthritis in equal or more than 5 joints and it is known that long term inflammation leads to bone deformities, cartilage damage and synovitis. signs and symptoms include pain and tenderness of joints, morning stiffness for more than 30 minutes, fever, fatigue and weight loss . Also, there are extra-articular manifestations like rheumatoid nodules , interstitial lung disease and ocular manifestations like scleritis . Many treatment approaches in RA are based on anti- inflammatory, anti-oxidant and immune suppressive drugs mainly DMARDs. Up till now, there is no anti-inflammatory agent that is both safe and effective equivalent to DMARDs which are first line of treatment and that can be a scientific gap that should be filled in future research prespectives.

L-Carnitine is a nutritional supplement that is used for enhancing performance in

exercises, valproic acid toxicity, Rett syndrome and in case of secondary carnitine deficiency like in end stage renal disease (ESRD). Physiologically, it is synthesized from lysine and methionine. It is involved in energy production by assisting in transportation of long chain fatty acid into the mitochondria where they undergo beta oxidation for ATP production. Several studies have successfully proven that it has antioxidant effect by activating PPAR gamma which is transcription factor that directly increases expression of antioxidant enzymes like super oxide dismutase (SOD) . LC also have anti-inflammatory effect by acting on PPAR gamma that also inhibits Nf-KB pathway, thus decreasing release of inflammatory mediators. That was mentioned in literature done on inflammatory diseases like coronary artery disease and sepsis . The need for an add on therapy in RA increases to improve response to treatment and provide cost effectiveness benefit that opens the door for repurposing trials.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Demerdash
      • Cairo, Demerdash, Egypt
        • Recruiting
        • Demerdash hospital
        • Contact:
          • Amr Hawwash, PhD
          • Phone Number: +2001123902218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age between 18-60 years old
  • diagnosed of rheumatoid arthritis according to 2010 American College of Rheumatology/European League Against Rheumatism criteria for at least 6 months
  • enrolled patients treated with one of more of conventional DMARDs for ≥ 6 months with stable dose for ≥ 1 month before start of the study
  • active RA despite conventional DMARDs treatment (DAS28 ESR more than or equal 3.2)
  • patient or legal representative should sign informed consent

Exclusion Criteria:

  • pregnant or lactating female
  • patients with liver dysfunction (>1.5x the upper limit of normal value for ALT & AST)
  • Patients with kidney dysfunction (serum creatinine more than 1.2 mg/dl)
  • Patients with any active infection or concurrent malignancy
  • patients with uncontrolled medical conditions or other rheumatic diseases
  • patients currently taking drugs that could interact with carnitine like: warfarin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: l-carnitine and conventional DMARDs
l-carnitine 500 mg ( carnitine tartrate 500 mg) two capsules twice daily for three months as add on therapy to conventional DMARDs.
Drug: Carnitine
It is a nutritional supplement with trade name " Carnitol®" in Egypt.
Drug: Disease-modifying anti-rheumatic drugs
They are immunosuppressive drugs used to improve disease activity in Rheumatoid Arthritis patients . Conventional DMARDs include methotrexate (Imutrexate®) , leflunomide(Arthfree®) , hydroxychloroquine (plaquenil®) and sulfasalazine(colosalazine®) .
Placebo Comparator: placebo and conventional DMARDs
placebo 500 mg two capsules twice daily for three months as add on therapy to conventional DMARDs.
Drug: Disease-modifying anti-rheumatic drugs
They are immunosuppressive drugs used to improve disease activity in Rheumatoid Arthritis patients . Conventional DMARDs include methotrexate (Imutrexate®) , leflunomide(Arthfree®) , hydroxychloroquine (plaquenil®) and sulfasalazine(colosalazine®) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in DAS28 ESR for both arms
Time Frame: From enrollment to the end of trial at 12 weeks
DAS 28-ESR is a score used to measure disease activity in RA patients. it is calculated using an equation where number of tender joints ( out of 28 joints) , number of swollen joints ( out of 28 joints) , patient assessment of disease activity ( using visual analogue scale from zero to 10) and ESR level are used as inputs to give DAS 28-ESR as output . the score will be measured to all participants both at baseline and at end of study. Higher scores indicate higher disease activity .
From enrollment to the end of trial at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients achieving ACR50% in both arms
Time Frame: From enrollment to the end of trial at 12 weeks
It is a score used to measure disease activity in RA patients. ACR 50% is achieved when patient have 50% improvement in tender and swollen joints count and three out of the following five : ESR level , patient assessment of disease activity ( using visual analogue scale from 0 to 10) , physician assessment of disease activity ( using visual analogue scale from 0 to 10) , pain assessment ( using visual analogue scale from 0 to 10) and health assessment questionnaire . this outcome will be assessed at end of trial.
From enrollment to the end of trial at 12 weeks
change in HAQ DI for both arms
Time Frame: From enrollment to the end of trial at 12 weeks

HAQ DI stands for health assessment questionnaire disability index that is used to reflect quality of life and functional disability where scores will vary from 0 to 3 and higher scores indicate more disability .

A validated Arabic copy will be used and measured both at baseline and at end of trial.
From enrollment to the end of trial at 12 weeks
change in TNF aplha for both arms
Time Frame: From enrollment to the end of trial at 12 weeks
anti inflammatory marker
From enrollment to the end of trial at 12 weeks
change in MDA for both arms
Time Frame: From enrollment to the end of trial at 12 weeks
It is an oxidative stress marker where higher values indicates more oxidative stress
From enrollment to the end of trial at 12 weeks
change in TAC for both arms
Time Frame: From enrollment to the end of trial at 12 weeks
It is an oxidative stress marker where higher values indicate better anti oxidant effect .
From enrollment to the end of trial at 12 weeks
safety data for both arms
Time Frame: From enrollment to the end of trial at 12 weeks
A list of drug related adverse events will be reviewed by patients at each follow up visit ( at end of each month ) and at end of study. It will be expressed as nominal data ( number of patients experienced a certain adverse event versus number of those who don't) .
From enrollment to the end of trial at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German University in Cairo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RACAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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