The Effect of Coenzyme Q10 Supplementation on the Clinical Outcome of Juvenile Idiopathic Arthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease Activity Evaluation
研究概览
简要总结
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatological disorder in childhood of unknown cause and a major cause of functional disability. Standard JIA treatment including nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, methotrexate, and biological agents have considerable adverse effects in addition to their high cost. Despite the success of these treatment approaches, patients may still have active disease with other sequelae from chronic inflammation and considerable morbidity that may negatively impact patients' quality of life. Therefore, evaluating the potential benefit of alternative add-on anti-inflammatories and antioxidants might be a promising area for further research. Coenzyme Q10 (CoQ10) is a natural mitochondrial electron carrier and a powerful lipophilic antioxidant located in almost all cell membranes and plasma lipoproteins. Several preclinical studies in animal models as well as clinical trials in adult patients with rheumatoid arthritis (RA) have demonstrated the beneficial effects of CoQ10. Results show that CoQ10 can reduce the oxidative and inflammatory status as well as clinical features that characterize this systemic autoimmune disease.
Also, CoQ10 has been used safely in children before and was well tolerated. Thus, the investigators would like to evaluate the effect of CoQ10 oral supplementation in pediatric JIA patients.
详细描述
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatological disorder in childhood of unknown etiology and a major cause of functional disability. It has a prevalence rate of about 1/1000 worldwide. The American College of Rheumatology (ACR) defines JIA as inflammation in one or more joints of unknown etiology with onset prior to age 16 years and a minimum of 6 weeks duration, following the exclusion of other known causes of synovitis. The International League of Associations for Rheumatology criteria classifies JIA into several different subgroups depending on the number of joints affected, presence of extra-articular manifestations such as uveitis or glomerulonephritis, systemic symptoms, serology and genetic factors. Peripheral arthritis is the common predominant clinical presentation among the various types. The three main types of JIA are polyarticular, oligoarticular, and systemic JIA. Therefore, diagnosis of JIA depends on physical findings, medical history, and the exclusion of other diagnoses.
The main hallmark of JIA is joint inflammation with bone resorption and tissue destruction.
This chronic inflammation limits the daily activities and productivity of patients. Interleukin-1 (IL-1), IL-6, IL-17, and tumor necrosis factor-α (TNF-α) are inflammatory cytokines that play an important role in the pathogenesis, prognosis, disease activity, and systemic features of JIA. Additionally, abnormal activation of T-cells, B-cells, natural killer (NK) cells, dendritic cells (DC), macrophages and neutrophils contribute to the pathogenesis of JIA.
All medications used to treat JIA including nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, methotrexate, and biological agents have considerable adverse effects in addition to the high cost of the biologics. Also, despite the success of these treatment approaches, patients may still have active disease with other sequelae from chronic inflammation and considerable morbidity that may negatively impact patients' quality of life. Therefore, evaluating the potential benefit of alternative add-on anti-inflammatories and antioxidants might be a promising area for further research.
Coenzyme Q10 (CoQ10) is a mitochondrial electron carrier and a powerful lipophilic antioxidant located in almost all cell membranes and plasma lipoproteins. It can be found naturally and acquired from the diet or synthesized in-vivo by all cells of the body. Various in-vitro and animal studies have demonstrated the antioxidant and anti-inflammatory effect of CoQ10.7 This has raised interest in its therapeutic potential against pathologies related to mitochondrial dysfunction and enhanced oxidative stress such as systemic autoimmune diseases.
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
- Single (Participant)
盲法说明
Placebo will be given to patients in the control group
入排标准
- 年龄范围
- 3 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (<16 years old)
- •Diagnosed with active JIA according to the American College of Rheumatology (ACR) 2019 guideline.
- •Patients with peripheral oligo or polyarthritis.
- •With more than 6-month disease duration
- •Participants who have inadequate response to at least one first line standard therapy.
- •Patients who have been receiving a stable treatment regimen for the past 3 months
排除标准
- •Patients with active systemic JIA
- •Patients presenting with complications (such as amyloidosis, uveitis, or glomerulonephritis)
- •Patients with other chronic autoimmune disease.
研究组 & 干预措施
Coenzyme Q10 Group
Patients will receive their JIA standard treatment plus 100 mg Coenzyme Q10 capsules daily for 3 months.
干预措施: Coenzyme Q10 (Dietary Supplement)
Coenzyme Q10 Group
Patients will receive their JIA standard treatment plus 100 mg Coenzyme Q10 capsules daily for 3 months.
干预措施: Standard Regimen (Drug)
Control Group
Patients will receive their standard JIA treatment plus placebo
干预措施: Placebo (Other)
Control Group
Patients will receive their standard JIA treatment plus placebo
干预措施: Standard Regimen (Drug)
结局指标
主要结局
Disease Activity Evaluation
时间窗: 3 months
Clinical efficacy will be assessed by calculating the Clinical Juvenile Arthritis Disease Activity Score (cJADAS-10) at baseline and at the end of the 3-month trial period. The cJADAS is computed by assessing the following variables: 1. Physician's global rating of overall disease activity 2. Parent/child ratings of well-being 3. Counts of active joints assessed in 10 joints
次要结局
- Serum Malondialdehyde(3 months)
- Serum Tumor necrosis factor-alpha(3 months)
- Safety of Coenzyme Q10(3 months)
- The Childhood Health Assessment Questionnaire (CHAQ)(3 months)
- serum glutathione(3 months)
研究者
Nourhan Elsherif
Clinical Pharmacy Master's Candidate
Ain Shams University
