Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Fasting Blood Lipid Profiles(TG levels)
研究概览
简要总结
Children with Chronic Kidney Disease (CKD) are at very high risk for cardiovascular morbidity and mortality. Hyper-lipidemia, a traditional risk factor for Cardiovascular Disease (CVD), occurs early in the progression of kidney failure; timely identification and intervention is prudent. Currently, there is no known effective therapy for hypertriglyceridemia, the most common lipid abnormality. n-3FA, in doses ranging from 2-6 g/day have effectively lowered elevated triglyceride (TG) levels by 20-50% in a variety of adult populations; however, their use in children with CKD has not been tested in a randomized controlled fashion. This study will provide important information on the safety, efficacy and tolerance of n-3FA in lowering elevated TG levels in children and adolescents with CKD.
详细描述
Following counseling on dietary and lifestyle changes to lower triglyceride levels, and a period of applying these modifications, children will be assigned in a random fashion to take either fish oil supplements or a placebo (soybean/corn oil) for 8 weeks. After this 8-week treatment period, children will not take a supplement for 4 weeks and then will be assigned the alternate product (fish oil or placebo) for another 8 weeks. Our main interest is to see whether there is a larger decrease in triglyceride levels after taking the fish oil supplement compared to the placebo.
The primary objective of this study is to determine whether omega-3 fatty acid supplements, given at therapeutic dosages over an 8-week period, significantly decrease elevated serum TG in children with CKD;
The secondary objectives of this study are:
i. To evaluate the effect of n-3 fatty acid supplements on total-, LDL-, and HDL-cholesterol;
ii. To determine whether n-3 fatty acid supplements are well tolerated by our study participants; and
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age at randomization: 2.0-17.4 years old (stratified by age: 2-8 yr, 9-13 yr, 14-17.4 yr)
- •CKD stages 3 or 4 (GFR:15-59 ml/min/1.73 m2)
- •established and stable in the CKD 3 and 4 Program for a minimum of 3 months
- •fasting serum TG 95th percentile for age and gender 2 on more than or equal to 2 occasions
排除标准
- •allergy to fish, corn, soybean
- •anti-coagulant or anti-platelet drugs (heparin, warfarin, therapeutic NSAIDs) or herbal products (ginko, garlic, feverfew, ginger and ginseng) known to prolong bleeding
- •currently undergoing treatment for dyslipidemia
- •use of dietary supplements containing n-3FA
- •children with Nephrotic Syndrome, on dialysis, or transplanted
- •planned surgery, dialysis or transplantation within the next 7 months
- •children with diabetes
- •bleeding and clotting disorders:
- •thrombocytopenia (platelet count <100 x 109/L), including ITP, TTP
- •Von Willebrands disease
- •hemophilia
- •thrombophilia
- •vitamin K deficiency
- •severe liver disease
- •unstable patients with shock which can lead to DIC (disseminated intravascular coagulation)
- •active Henoch Schonlein Purpura
- •hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber disease)
结局指标
主要结局
Fasting Blood Lipid Profiles(TG levels)
时间窗: Week 1,4,12,16,24 and 28
次要结局
- Platelet aggregation(Week 1,4,12,16,24 and 28)
- CBC(Week 1,4,12,16,24 and 28)
- Cholesterol Levels (LDL and HDL)(Week 1,4,12,16,24 and 28)
- Tolerability of n-3 fatty acid supplements by our participants(Week 1,4,12,16,24 and 28)
研究者
Elizabeth Harvey
Nephrologist
The Hospital for Sick Children