A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Increases in omega-3 fatty acid levels in plasma and red blood cell membranes observed in each of the three omega-3 supplements used in this study
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of nutritional supplements in increasing the amount of omega-3 fatty acids (and arginine) in the red blood cell membranes and plasma of kidney transplant patients, and, secondarily, to compare patient compliance. The long-term goal of this study is to develop low risk therapies that will allow improved and lasting survival of donor tissue with minimal suppression of the immune system.
详细描述
Short-term survival rates of donor tissue after kidney transplantation have improved significantly in recent years because of improved immunosuppression. Rates of long-term tissue loss have changed less because of a high incidence of chronic rejection, infectious complications, and cardiovascular disease. Data suggest that both early and late complications might be reduced in transplant recipients by dietary intervention to raise levels of omega-3 fatty acids and arginine.
Prior to transplantation, participants are randomized to one of three groups. Group 1 participants serve as controls and receive no dietary supplements. Participants in Group 2 receive daily nutritional supplements of arginine and canola oil according to body weight. Group 3 participants receive daily nutritional supplements of arginine and a fish oil emulsion according to body weight. All participants receive a standard, low-fat dietary consultation. The status of participants is evaluated peri-transplant and at 1, 3, 6, and 9 months.
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
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease.
- •Candidate to receive a living-related donor, living unrelated donor, or first cadaver kidney with at least 1 HLA mismatch.
- •Negative crossmatch with the intended donor.
- •Adults must have moderate to severe hypertension and/or take at least 1 medication for hypertension daily.
- •Willingness to comply with the dietary supplements, including canola oil, a flavored drink mix, or an orange flavored pudding.
排除标准
- •Pregnancy or breast-feeding.
- •Women of childbearing age who are not willing or able to practice acceptable methods of contraception.
- •HIV-positive.
- •Positive test for HBV E-AG/DNA and HCV.
- •Received an organ transplant or plan to receive a multiple organ transplant.
- •Phenylketonuria.
- •Participation in other investigational studies within 30 days of the renal transplant.
- •Allergy or anaphylactic reactions to eggs or L-arginine.
- •ABO blood incompatibility.
- •Children who have previously received more than 5 blood transfusions.
- •History of stroke.
结局指标
主要结局
Increases in omega-3 fatty acid levels in plasma and red blood cell membranes observed in each of the three omega-3 supplements used in this study
次要结局
- Compliance rates observed in each of the three study groups