Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
OBJECTIVES:
I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.
详细描述
PROTOCOL OUTLINE:
This is a randomized, double blind, placebo controlled study.
Patients receive either daily choline chloride in their total parenteral nutrition (TPN) solution or their usual TPN. The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly. Therapy continues for 24 weeks. Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance. Additionally, all patients record the type and amount of their food intake on a daily basis.
Patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning with week 12 for the remainder of the 24 weeks, and then again at week 34.
Completion date provided represents the completion date of the grant per OOPD records
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Receiving nightly total parenteral nutrition (TPN) for greater than 70% of nutritional needs for a minimum of 8 weeks prior to study entry; Receiving no greater than 38 kcal/kg/day/ideal body weight; Receiving lipid emulsion as part of TPN regimen
- •Expected to require TPN for at least 34 weeks after study entry
- •Hepatic steatosis documented by prestudy CT scan
- •Consistent daily amount of intravenous amino acids, dextrose, or lipid received for 3 weeks prior to study entry
- •-Prior/Concurrent Therapy--
- •No concurrent cholinergic medications
- •-Patient Characteristics--
- •Hepatic: Albumin at least 3.5 g/dL; No hepatic failure; PT no greater than 2 times upper limit of normal
- •Renal: No renal failure requiring hemo- or peritoneal dialysis
- •Other: No AIDS; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
排除标准
- 未提供