Evaluation of the Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mitochondrial dysfunction
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are:
- What is the impact of coenzyme Q10 supplementation on mitochondrial dysfunction?
- Does it have a beneficial effect on disease activity through assessment of the systemic lupus erythematosus disease activity index (SLEDAI) score?
Researchers will compare the group of patients that take coenzyme Q10 to a group that doesn't to see if coenzyme Q10 supplementation works to decrease mitochondrial dysfunction and disease activity.
Participants will:
Take coenzyme Q10 plus the standard treatment of SLE or the standard treatment only every day for 3 months.
Visit the clinic once every 4 weeks for checkups and tests.
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
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders aged 6-16 years old diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of SLE.
- •Patients with moderate to severe activity presenting with lupus nephritis.
排除标准
- •Patients taking over-the-counter antioxidants such as N-acetylcysteine, vitamin E, omega-3 fatty acids, L-carnitine, or vitamin C.
- •Patients with very severe active SLE that might threaten vital organs.
- •Patients with chronic infections and severe and recurrent infections, whether bacterial, viral, or fungal infection
研究组 & 干预措施
Coenzyme Q10 group
Group 1 (Coenzyme Q10 group): consists of 30 patients who will receive one capsule containing 100 mg Coenzyme Q10 once daily for 12 weeks, "Coenzyme Q10 Forte® ".
干预措施: Coenzyme Q10 (Drug)
Control group
Group 2 (Control group): consists of 30 patients who will not receive the intervention.
结局指标
主要结局
Mitochondrial dysfunction
时间窗: 3 months
Through assessment of the NLRP3 inflammasome and type 1 IFN (IFN-α).
次要结局
- systemic lupus erythematosus disease activity index (SLEDAI) score.(3 months)
- The safety and tolerability of Coenzyme Q10(3 months)
研究者
Helal
Demonstrator of clinical pharmacy department at faculty of pharmacy Ain shams university
Ain Shams University