A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 9
- 主要终点
- Change of Liver Function Parameters From Baseline to Visit 2
研究概览
简要总结
The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lipidem
i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)
干预措施: Lipidem (Drug)
Lipofundin MCT
i.v. lipid emulsion
干预措施: Lipofundin MCT 20% (Drug)
结局指标
主要结局
Change of Liver Function Parameters From Baseline to Visit 2
时间窗: 8 weeks
Changes will be expressed as the sum of the N(0.1)- transformed differences of bilirubin, ALT and AST (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters.
次要结局
- Bilirubin(8 weeks)
- Alanine Transaminase (ALT)(8 weeks)
- Aspartate Transaminase (AST)(8 weeks)
- AST/ALT Ratio(8 weeks)
- Alkaline Phosphatase (ALP)(8 weeks)
- Gamma-glutamyl Transpeptidase (GGT)(8 weeks)
- White Blood Cells (WBCs)(8 weeks)
- Red Blood Cells (RBCs)(8 weeks)
- International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)(8 weeks)
- Potassium(8 weeks)
- Calcium(8 weeks)
- Hemoglobin (Hb)(8 weeks)
- Blood Glucose(8 weeks)
- Cholesterol(8 weeks)
- High-density Lipoprotein (HDL)(8 weeks)
- Low-density Lipoprotein (LDL)(8 weeks)
- Platelets(8 weeks)
- Activated Partial Thromboplastin Time (aPTT)(8 weeks)
- Hematocrit (Hct)(8 weeks)
- Sodium(8 weeks)
- Chloride(8 weeks)
- Magnesium(8 weeks)
- Phosphate(8 weeks)
- Serum Creatinine(8 weeks)
- Triglycerides(8 weeks)
- α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)(8 weeks)
- Adverse Events(8 weeks)
- C-reactive Protein (CRP)(8 weeks)
- Triene:Tetraene Ratio in Plasma, Reduction From Baseline(8 weeks)
- BMI(8 weeks)
- Prothrombin Time (PT)(8 weeks)