NCT02646995已完成不适用
Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Difference of accretion in erythrocytes of eicosapentanoic acid (EPA) between the 2 groups from Baseline to V3 (12 weeks of treatment), as determined by gas chromatography
研究概览
简要总结
The purpose of this trial is to evaluate if the use of a newly developed lipid formulation versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of supplementation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed CF according to established criteria (diagnosis of CF will be based on either two positive sweat chloride tests of >60 mEq/L or the identification of two detectable mutations associated with CF)
- •Exocrine pancreatic insufficiency defined by pathological fecal elastase (<15µg/g) found in the Medical History of the patient
- •Informed consent letter signed and dated by their parents or legal guardians before inclusion in the study, and assent signed and dated by the child if he or she is ≥ 14 years old
排除标准
- •Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to baseline
- •Exposure to another investigational drug or dietary supplements and enteral nutrition containing EPA and docosahexaenoic acid (DHA), Fish or the use of any other supplement containing fish oil within 4 weeks prior to baseline.
- •Treatment with intravenous antibiotics within 4 weeks prior to baseline
- •Newly started oral antibiotic treatment within 4 weeks prior to Baseline
- •History of solid organ or hematological transplantation
- •Ongoing immunosuppressive therapy (other than corticosteroids) within 3 weeks prior to baseline
- •Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to baseline
- •Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to baseline
- •Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study
- •Any bleeding disorders at screening
- •Patient who cannot be expected to comply with the study procedures.
- •Currently participating or having participated in another clinical trial within 8 weeks prior to baseline.
- •Any known food allergy
- •Incapacity to swallow capsules
研究组 & 干预措施
Active
Experimental
modified lipid formulation
干预措施: modified lipid formulation (Dietary Supplement)
Control
Active Comparator
fish oil
干预措施: Fish oil (Dietary Supplement)
结局指标
主要结局
Difference of accretion in erythrocytes of eicosapentanoic acid (EPA) between the 2 groups from Baseline to V3 (12 weeks of treatment), as determined by gas chromatography
时间窗: From Baseline till 12 weeks of treatment (V3)
determine the accretion in erythrocytes of EPA derived from the modified lipd formulation as compared to EPA from fish oil between the 2 groups after 12 weeks of supplementation
次要结局
未报告次要终点
研究者
研究点 (2)
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