A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.
研究概览
简要总结
L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is involved in transporting fatty acids across the mitochondrial membrane, it could be an important component in treating a fatty liver disease.
The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine and Magnesium as a treatment for fatty liver.
详细描述
A phase 3, randomized, double blind placebo controlled study that evaluate the efficacy of L-Carnitine and Magnesium as a treatment for fatty liver, 60 eligible patients with a diagnosis of NAFDL will be randomly assigned in a 1:1 ratio to receive either the trial product " SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks, or placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". 'Follow up time is estimated to be 24 week based on monthly clinic visits and accordingly assessment of lipid profile, weight and insulin resistance.
Fibrotest will be used at the beginning of the trial and at the end (week 16) comparing the fat content before and after the treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female between the age 18 and
- •Patients with diagnosis of NAFLD when other etiologies for fatty liver were ruled out.
- •Patients who sign a confirmed consent.
排除标准
- •Patients with liver failure.
- •Patients with acute or chronic renal failure ( CCT< 50 ml/min or creatinine > 1.5 mg/dl)
- •Patients with congestive heart failure (NYHA 3-4)
- •Patients with active cancer
- •Patients on Estrogen therapy, MTX, chloroquine.
- •Patients with a history of Hypothyroidism or Cushing disease.
- •Patients who received TPN in the past 6 months.
- •Patients with chronic liver disease, A1AT, Hemochromatosis, Wilson, Autoimmune, Toxic injury.
- •Patients on anticoagulation therapy - Coumadin.
- •Patients who use valproic acid therapy.
- •Children, Pregnancy.
研究组 & 干预措施
Primary treatment Arm
patients with a diagnosis of NAFDL will be randomly receive trial product "SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks.
干预措施: "SLIM WATER" (Dietary Supplement)
Placebo Arm
patients with a diagnosis of NAFDL will be randomly receive placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER".
干预措施: Placebo - water (Other)
结局指标
主要结局
The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.
时间窗: 24 weeks
Measured with blood test in IU/L
Decline in serum levels of Alanine transaminase (ALT) to normal value.
时间窗: 24 weeks
Measured with blood test in IU/L
次要结局
- Improvement in radiological hepatic steatosis .(24 weeks)
- Improvement in lipid profile.(24 weeks)
研究者
Rawi Hazzan
Principal Investigator
HaEmek Medical Center, Israel