Effect of Antioxidant Supplements on Oxidative Stress, Disease Severity and Bacterial Infection in Cystic Fibrosis Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- evaluate the effect of antioxidants supplementation on the level of oxidative stress among CF children..
研究概览
简要总结
This randomized controlled clinical trial included 60 pediatric patients with cystic fibrosis (CF) assigned randomly into two arms; Arm 1(extra care arm):received a tailored dietary plan following Mediterranean diet to cover macronutrients needs according to recommended daily allowance (RDA) for age, with antioxidant supplements in specific doses in oral liquid form (200 mg vitamin E, 300 mg vitamin C, 90 μg Se, 500 μg vitamin A, 30 mg zinc, 3 mg copper and 2000 IU vitamin D) for 6 months. Arm 2: recieved tailored dietary plan following Mediterranean diet as Arm 1 with fat soluble vitamins supplementation (150 μg vitamin A, 2000 IU vitamin D, 100 mg vitamin E and 1000 μg vitamin K) for 6 months. This study aimed to evaluate the effect of antioxidants supplementation on the level of oxidative stress, as measured by 3-Nitrotyrosine, bacterial colonization and diseases severity among CF children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented diagnosis of cystic fibrosis (CF) who were diagnosed according to CF Foundation guidelines based upon positive sweat tests and/or the presence of a mutation in the homozygous state or two heterozygous mutations on the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein
排除标准
- •Patients with current pulmonary exacerbations.
- •Patients with severe sepsis.
- •Patients with comorbid systemic illnesses.
研究组 & 干预措施
Arm 1(Extra care group)
干预措施: Mediterranean diet (Other)
Arm 1(Extra care group)
干预措施: Antioxidant Supplement (Dietary Supplement)
Arm 2
干预措施: Mediterranean diet (Other)
Arm 2
干预措施: Fat soluble vitamins supplementation (Dietary Supplement)
结局指标
主要结局
evaluate the effect of antioxidants supplementation on the level of oxidative stress among CF children..
时间窗: 6 months
To evaluate the effect of antioxidants supplementation on the level of oxidative stress, as measured by 3-Nitrotyrosine, bacterial colonization and diseases severity among CF children.
次要结局
未报告次要终点
研究者
Haya Essam Ibrahim
Lecturer of pediatrics
Ain Shams University