Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
ID06753565

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

Led by German University in Cairo · Updated on 2025-01-07

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of l-carnitine as an add-on therapy to improve outcomes in patients with rheumatoid arthritis (RA), an inflammatory autoimmune disease that mainly affects joints like the hands, wrists, and feet. The disease is more common in females and is linked to genetic and environmental factors that trigger an autoimmune response. RA causes symmetrical joint inflammation, leading to pain, stiffness, fatigue, and sometimes affects other organs. Current treatments rely on anti-inflammatory and immune-suppressing drugs called DMARDs, but there is a need for safer, effective alternatives. This phase 2 trial compares l-carnitine supplementation with conventional disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine. L-carnitine, a nutritional supplement known for its antioxidant and anti-inflammatory properties, is given alongside standard therapy. Participants will continue their stable DMARD treatments while adding l-carnitine. The study duration is 12 weeks. Participants will undergo assessments of disease activity using the DAS28 ESR score from enrollment through the 12-week trial period. Researchers will monitor changes in joint inflammation and overall disease activity to evaluate the impact of l-carnitine. Safety assessments will include monitoring liver and kidney function and any side effects. The study aims to provide new insights into improving RA management with an affordable supplemental treatment option.

CONDITIONS

Official Title

L-carnitine Supplementation in Rheumatoid Arthritis Patients

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years old
  • Diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR criteria for at least 6 months
  • Currently treated with one or more conventional DMARDs for 6 months or more with stable dose for 1 month before study start
  • Active rheumatoid arthritis with DAS28 ESR score of 3.2 or higher
  • Patient or legal representative has signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or lactating females
  • Liver dysfunction with ALT or AST greater than 1.5 times the upper normal limit
  • Kidney dysfunction with serum creatinine over 1.2 mg/dl
  • Any active infection or concurrent cancer
  • Uncontrolled medical conditions or other rheumatic diseases
  • Taking drugs that may interact with carnitine, such as warfarin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Demerdash hospital

Cairo, Demerdash, Egypt

Actively Recruiting

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Research Team

M

Mariam Ehab, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update.

Josef S Smolen, Robert B M Landewé, Johannes W J Bijlsma...

https://pubmed.ncbi.nlm.nih.gov/31969328

A large observational cohort study of rheumatoid arthritis, IORRA: Providing context for today's treatment options.

Hisashi Yamanaka, Eiichi Tanaka, Ayako Nakajima...

https://pubmed.ncbi.nlm.nih.gov/31475852

L-carnitine ameliorates the liver inflammatory response by regulating carnitine palmitoyltransferase I-dependent PPARγ signaling.

Fang Jiang, Zongqi Zhang, Yi Zhang...

https://pubmed.ncbi.nlm.nih.gov/26647854

Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study.

Tim Bongartz, Carlotta Nannini, Yimy F Medina-Velasquez...

https://pubmed.ncbi.nlm.nih.gov/20155830

The importance of differences; On environment and its interactions with genes and immunity in the causation of rheumatoid arthritis.

L Klareskog, J Rönnelid, S Saevarsdottir...

https://pubmed.ncbi.nlm.nih.gov/32176395
Effect of L-carnitine Supplementation on Disease Activity in Rheumatoid Arthritis Patients | DecenTrialz