Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo
研究概览
简要总结
Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Months 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of cystic fibrosis over than 2 months age
- •Tolerance clinical supplementation with DHA
- •Clinical situation stable
排除标准
- •Changes in the routine treatment in the 2 weeks prior to baseline
- •Admission to hospital or administration of oral or intravenous antibiotics within 2 weeks before inclusion
研究组 & 干预措施
Docosahexaenoic acid administration
50 patients will receive docosahexaenoic acid
干预措施: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months (Dietary Supplement)
placebo
50 patients will receive placebo
干预措施: Placebo: 50 mg/kg/day during 12 months (Dietary Supplement)
结局指标
主要结局
To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo
时间窗: 12 months
次要结局
未报告次要终点