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临床试验/NCT06753565
NCT06753565招募中2 期

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

German University in Cairo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
60
试验地点
1
主要终点
change in DAS28 ESR for both arms

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

l-carnitine and conventional DMARDs

Experimental

l-carnitine 500 mg ( carnitine tartrate 500 mg) two capsules twice daily for three months as add on therapy to conventional DMARDs.

干预措施: Carnitine (Drug)

l-carnitine and conventional DMARDs

Experimental

l-carnitine 500 mg ( carnitine tartrate 500 mg) two capsules twice daily for three months as add on therapy to conventional DMARDs.

干预措施: Disease-modifying anti-rheumatic drugs (Drug)

placebo and conventional DMARDs

Placebo Comparator

placebo 500 mg two capsules twice daily for three months as add on therapy to conventional DMARDs.

干预措施: Disease-modifying anti-rheumatic drugs (Drug)

结局指标

主要结局

change in DAS28 ESR for both arms

时间窗: 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 .

次要结局

  • proportion of patients achieving ACR50% in both arms(From enrollment to the end of trial at 12 weeks)
  • change in HAQ DI for both arms(From enrollment to the end of trial at 12 weeks)
  • change in TNF aplha for both arms(From enrollment to the end of trial at 12 weeks)
  • change in MDA for both arms(From enrollment to the end of trial at 12 weeks)
  • change in TAC for both arms(From enrollment to the end of trial at 12 weeks)
  • safety data for both arms(From enrollment to the end of trial at 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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