RecruitingPhase 2NCT06753565

L-carnitine Supplementation in Rheumatoid Arthritis Patients

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

Sponsor

German University in Cairo

Enrollment

60 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

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 Criteria6

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

Interventions

DRUGCarnitine

It is a nutritional supplement with trade name " Carnitol®" in Egypt.

DRUGDisease-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®) .