Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Measurement the area under the curve of absorption of vitamin E according to its dosage form (fat-soluble versus water-soluble) in the beginning of each treatment period. versus water-soluble) in the beginning of each treatment period.
研究概览
简要总结
To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the classical lipid-soluble form in a population of patients with intestinal malabsorption (hypocholesterolemias family by retention of chylomicrons).
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
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient suffering from familial hypocholesterolemia by retention of chylomicrons
- •Systematically followed in the department of Gastroenterology and Paediatric Nutrition in Women Mother Child's Hospital or in the endocrinology department of GHE (Louis Pradel Hospital);
- •During treatment with oral vitamin E;
- •over the age of 3 years and weighing over 16 kg at the time of inclusion
- •For which there is a signed informed consent from the patient or parents / guardians in the case of a minor patient, and benefit from social security coverage.
排除标准
- •Patient with encephalopathy
- •Hypersensitivity to the active substance or the excipients of Vedrop
- •A suspected allergy to local anaesthetics (including xylocaine)
- •Patients who may not be compliant to treatment (psychiatric);
- •In case of refusal to participate in the study from the patient and / or parents or legal guardian;
- •Patients unable to consent (if patients with encephalopathy)
研究组 & 干预措施
Tocofersolan: Vitamin E water-soluble
2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
干预措施: Tocofersolan (Drug)
Tocopherol alpha: Vitamin E conventional fat-soluble form
2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
干预措施: tocopherol alpha (Drug)
volunteers
干预措施: Tocofersolan and tocopherol alpha (Drug)
结局指标
主要结局
Measurement the area under the curve of absorption of vitamin E according to its dosage form (fat-soluble versus water-soluble) in the beginning of each treatment period. versus water-soluble) in the beginning of each treatment period.
时间窗: 12 months
次要结局
- Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment.(12 months)
- Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment.(12 months)