Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Efficacy parameters: Characterize the reduction in ALT levels.
研究概览
简要总结
This trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased ALT.
详细描述
Over the past two decades, pre-adult nonalcoholic fatty liver disease (NAFLD) has emerged from the relative obscurity to become the most common cause of liver disease in pediatric patients. Currently, over 17% of US children and adolescents have a BMI at or greater than the 95th percentile for age and gender and 20% of children in weight management programs are estimated to have NAFLD. Untreated NAFLD can lead to fibrosis and to established cirrhosis in children as young as 10. Fish oils are a rich source of omega-3-acid ethyl esters or n-3 long-chain polyunsaturated fatty acids, and increasing evidence suggest they may safely improve hepatic steatosis. Given the prevalence of obesity, of NAFLD, and the severe, progressive nature of this condition, effective treatment strategies are urgently needed. We plan to gather preliminary data on the efficacy and safety of fish oil supplements in reducing persistent elevation of ALT levels and hepatic steatosis on abdominal CT-scan among urban youth (BMI>=95th percentile). This preliminary data will provide the necessary information to calculate the sample size for a phase 2 trial.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI (kg/m2) at or above the 95th percentile for age and gender
- •Weight below 400 pounds (less than 182 kilograms)
- •Persistent elevation of ALT (41-90 UI/L at study screening)
- •Presence of hepatic steatosis on abdominal CT-scan
- •Able to give informed consent/assent
排除标准
- •Type 2 diabetes mellitus
- •Prior drug treatment for diabetes, insulin insensitivity, or weight loss medications six months before screening
- •Use of prescription strength glucocorticoids within three months before screening
- •History of syndrome or medical disorder associated with significant obesity
- •Participation in a weight loss program within six months of screening resulting in 5% or more weight loss
- •History of weight loss surgery
- •Alcohol use more than twice weekly or more than 3 alcohol containing beverages within a 24-hour period in the past six months
- •Known or suspected bleeding condition
- •History of liver disease including prior liver biopsy with NASH type 2 or cirrhosis
- •Former or present positive blood tests for Infectious hepatitis B or C, autoimmune hepatitis, Wilson disease, Alpha-1 anti-trypsin deficiency, Iron storage disease, or high TSH
- •History of past or current pregnancy
- •Use of illegal/illicit drugs
- •Other conditions contraindicated or cause for caution in the use of fish oil
- •Unable to comply with the protocol
- •Any other serious disease determined by the study gastroenterologists and physician nutrition specialist as potential study risk for the patient
研究组 & 干预措施
Fish oil
Omega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g)
干预措施: Omega-3-acid ethyl esters (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy parameters: Characterize the reduction in ALT levels.
时间窗: 3 and 6 months from baseline
Safety/compliance parameters: Describe the safety blood tests results, review of systems, and physical examination at baseline, mid point, and end of treatment, as well as identify adverse events and compliance parameters at study contacts.
时间窗: From baseline to end of treatment
次要结局
- Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.(3 and 6 months from baseline)
研究者
Carine Lenders
Carine Lenders, MD, MS, ScD
Boston University