An Initial Trial of Enteral Fish Oil Supplementation in the Treatment of Parenteral Nutrition-associated Liver Disease in Patients With Short Bowel Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Normalization of ALT
研究概览
简要总结
The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not
详细描述
This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.
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
- 30 Days 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of parenteral nutrition(PN)administration >4weeks
- •PN associated liver disease from intestinal failure
- •ability to take full enteral feed
- •body weight equal or greater than 3kg
- •elevated ALT level twice of that normal(ALT>84)at the time PN is weaned off
排除标准
- •Hemodynamic instability
- •renal failure
- •suspected congenital obstruction of the hepatobiliary system
- •diagnosis hepatitis A, B, or C
- •diagnosis of alpha 1-antitrypsin deficiency
- •diagnosis of cytomegalovirus infection
- •diagnosis of HIV
- •children in care
研究组 & 干预措施
Lovaza group
Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day
干预措施: Lovaza (omega-3-acid ethyl ester) (Drug)
Placebo group
Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day
干预措施: Corn oil (Dietary Supplement)
结局指标
主要结局
Normalization of ALT
The primary aim is to examine the efficacy of Lovaza, when compared to placebo, on normalizing liver function, as measured primarily by amino alanine transferase (ALT). The investigators believe that patients in the Lovaza group will normalize ALT faster than in the placebo group.
次要结局
- Normalization other liver function tests and inflammatory status
研究者
Tom Jaksic
W. Hardy Hendren Professor of Surgery, Harvard Medical School
Boston Children's Hospital