Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change in 8-isoprostane level in urine.
研究概览
简要总结
Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status.
In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma and platelet lipid compositions will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 30 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L and a pancreatic insufficiency.
- •Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years
- •Body weight > 26 kg
- •Stable CF disease as judged by the investigator.
- •Subjects must have an Forced Expiratory Volume at one second > 40 % of predicted normal for age, sex and height at the screening visit.
- •Subjects should not have enteral or parenteral nutrition.
- •No periodic IV lipidic emulsion administration. Subjects must not consume food supplements rich in OMEGA-3 on a regular basis.
排除标准
- •Subjects with cirrhosis and portal hypertension.
- •Subjects with Cystic fibrosis related diabetes.
- •Concomitant participation in another clinical study.
- •Known allergy or intolerance to the active principle.
- •Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).
- •Subjects on a transplant waiting list.
研究组 & 干预措施
Docosahexaenoic acid
Each capsule of DHA contains 100 mg DHA in triglycerides from algal oil, 0.125 mg alpha-tocopherol and 0.125 mg ascorbic acid.
Subjects receive an orally and daily ingestion of DHA capsules (5mg/kg for 15 days followed by 10 mg/kg for another 15 days without interruption between the 2 periods).
干预措施: Docosahexaenoic acid (Drug)
Sunflower oil
Placebo capsules contain the same quantities of antioxidants and triglycerides of sunflower oil. Subjects receive an orally and daily ingestion of placebo capsules for 28 days.
干预措施: Sunflower Oil (Drug)
结局指标
主要结局
Change in 8-isoprostane level in urine.
时间窗: Day 14
Measured by urinalysis (Immunoassay).
次要结局
- Change in 11-dehydro-thromboxane B2 in urine.(Day 28)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Day 28)
- Change in percent predicted forced expiratory volume in 1 second(from baseline through Day 28)
- Evaluation of the effect of DHA on specific biomarkers.(Day 28)