Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum concentration of ascorbic acid (Cmax)
研究概览
简要总结
The aim of the study was to compare the profiles of vitamin C serum concentration in healthy volunteers after the single oral administration either in a liposomal or traditional formulation.
详细描述
The randomized, double-blind, cross-over study was conducted under the supervision of physician on a group of 10 healthy subjects. The volunteers received 1g of vitamin C in a traditional formulation (powder in capsules), and after 14 days of a washout period 1 gram of liposomal formulation (powder in capsules). Venous blood was collected from each participant of the study immediately before the administration of a studied substance and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 24 hours post the administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men, 18-65 years old.
- •Signed informed consent.
- •No injuries or hospitalizations within the last 3 months.
- •Refraining from consuming any vitamin C supplements or foods enriched with vitamin C for a period of 72 hours. Limiting excessive consumption of red peppers, parsley (stalks), Brussels sprouts, broccoli, turnip, tomatoes, cabbage, spinach, watercress, citrus fruits, and citrus juices. Not taking acetylsalicylic acid (aspirin, polopiryna, etopiryna) during the study.
- •Participants should fast for at least 8-12 hours prior to the administration of the preparations.
排除标准
- •Unwilling to give consent.
- •Injuries within the last 3 months.
- •Cancer (current or past).
- •Renal dysfunction (eGFR < 60 ml/min).
- •Gastrointestinal disorders (including use of antacids).
- •Tobacco use in any form.
- •Pregnancy/breastfeeding.
- •Patient after organ transplantation, after a stroke, use of anticoagulants, use of immunosuppressants.
- •Female patient receiving hormonal therapy (contraception).
结局指标
主要结局
Maximum concentration of ascorbic acid (Cmax)
时间窗: baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration
Maximum concentration of ascorbic acid achieved in the blood after administration of both formulations
Total amount of ascorbic acid that has been absorbed, defined as AUC
时间窗: baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration
Comparison of the bioavailability of formulations based on the total amount of ascorbic acid that has been absorbed, defined as AUC (area under the curve)
次要结局
- Concentration of ascorbic acid after 24 hours (C24h)(24 hours post the administration)