Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia
试验速览
- 阶段
- 不适用
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Plasma plant sterol level
研究概览
简要总结
If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma concentrations of sitosterol and other plant sterols in sitosterolemia patients.
详细描述
Ezitimibe significantly lowers plant sterol levels in the blood of patients with sitosterolemia. However, plant sterol levels remain substantially elevated compared to those in healthy individuals. Thus, combination therapy needs to be considered. Agents that provide cardiovascular benefits such as colesevelam, a second-generation bile acid sequestrant, and fish oil are potential candidates to help further reduce sterol levels, but have yet to be evaluated in sitosterolemia patients.
The purpose of this study is to dtermine the effects of colesevelam, fish oil and combination therapy (fish oil + colesevelam) on plant sterols, cholesterol and cardiovascular risk factors in sitosterolemia patients treated with ezetimibe. The results of this study will enhance knowledge on the pathogenesis of sitosterolemia and the mechanisim of actions of colesevelam and fish oil as adjunct therapies to ezitimibe in patients with the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of homozygous sitosterolemia as established by genotyping and/or clinical parameters
- •Receiving ezetimibe treatment
- •Over 8 years of age (no maximum)
- •Concomitant illnesses or conditions
排除标准
- •Intellectual disability
- •Bowel or biliary obstruction
- •Known hypersensitivity to colesevelam or any ingredients of colesevelam
研究组 & 干预措施
Colesevelam
3.75g/day for 6 weeks
干预措施: Colesevelam (Drug)
Fish Oil
1g/day for 6 weeks
干预措施: Fish Oil (Dietary Supplement)
Combination of Fish Oil and Colesevelam
3.75g/day of colesevelam and 1g/day of fish oil for 6 weeks
干预措施: Combination of fish oil and colesevelam (Drug)
结局指标
主要结局
Plasma plant sterol level
时间窗: 32 weeks
plasma plant sterol assessment using Gas Chromatography(GC)
次要结局
- endothelial functions(32 weeks)
- Fatty acid(32 weeks)