Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Lung and systemic inflammation measurement
研究概览
简要总结
Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific metabolites involved in the resolution of inflammation.
The PREMDIC project, initiated at the Centre Hospitalier Universitaire de Sherbrooke, is a randomized double-blind study for people with cystic fibrosis (CF) and aims to evaluate whether daily supplementation monoglyceride of DHA (a fatty acid omega-3 family) will reduce lung inflammation and improve pulmonary function.
详细描述
The goal of the study is:
To investigate the efficacity of oral administration of MAG-DHA to increase DHA bioavailability and reduce lung inflammation of patients with cystic fibrosis
The specific objectives of the project are :
- Determine the effect of MAG-DHA on lipid membranes of the blood mononuclear cells.
- Evaluate the effect of MAG-DHA on lung inflammation (determination of Human leukocyte elastase and alpha1 antitrypsin complexes : pHLE).
For this study, 20 cystic fibrosis patients are recruited. Patients are divided into 2 groups of 10 and received a daily dose equivalent to 3 g of placebo (sunflower oil) or MAG-DHA.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •forced expiratory volume in 1 second (FEV1) between 30 - 90%.
- •no respiratory exacerbations during the last 2 weeks before the start of the study
- •not have clotting problems or a history of bleeding diathesis
- •patients with liver function abnormalities are included in the study
排除标准
- •pregnant women or those not using contraception.
- •known allergy to fish and / or seafood.
研究组 & 干预措施
MAG-DHA
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
干预措施: MAG-DHA (Dietary Supplement)
Placebo
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Lung and systemic inflammation measurement
时间窗: 0 and 90 days
Docosahexaenoic acid (DHA) and metabolites lipid analyses in plasma and red blood cells Human leukocyte elastase and alpha1 antitrypsin complexes detection in plasma Pulmonary function test (spirometry): Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) Leukocytes differential cell counts and C reactive protein (CRP) determination level in blood
次要结局
- follow up of vital signs(0 and 90 days)
- lipid profile(0 and 90 days)
- hepatic function(0 and 90 days)