L-carnitine Supplementation in Rheumatoid Arthritis Patients
ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGerman University in Cairo
About this trial
This study aims to evaluate the effect of l-carnitine as add- on therapy for improving the outcome in rheumatoid arthritis patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Carnitine
DrugIt is a nutritional supplement with trade name " Carnitol®" in Egypt.
Disease-modifying anti-rheumatic drugs
DrugThey are immunosuppressive drugs used to improve disease activity in Rheumatoid Arthritis patients . Conventional DMARDs include methotrexate (Imutrexate®) , leflunomide(Arthfree®) , hydroxychloroquine (plaquenil®) and sulfasalazine(colosalazine®) .
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: l-carnitine and conventional DMARDsExperimental treatment 2 interventions
Group B: placebo and conventional DMARDsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
change in DAS28 ESR for both arms
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 .
Time frame
From enrollment to the end of trial at 12 weeksSecondary outcomes
1
proportion of patients achieving ACR50% in both arms
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.
Time frame
From enrollment to the end of trial at 12 weeks2
change in HAQ DI for both arms
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.
Time frame
From enrollment to the end of trial at 12 weeks3
change in TNF aplha for both arms
anti inflammatory marker
Time frame
From enrollment to the end of trial at 12 weeks4
change in MDA for both arms
It is an oxidative stress marker where higher values indicates more oxidative stress
Time frame
From enrollment to the end of trial at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov