A prospective survey of plasma levels of vitamin K2-7 (MK-7) in healthy volunteers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary objective is to study the levels of Vitamin K2-7 in healthy volunteers
研究概览
简要总结
After subjects meet the eligibility criteria an informed consent form (ICF) will be signed before inclusion into the trial. The subjects will undergo besides a detailed history and complete physical examination.
For the blood tests 20 cc of blood will be collected in fasting state. A detailed medical history will be taken at the time of screening. Clinical Examination of each subject will be done and recorded in the Case Record Form (CRF).
The samples will be centrifuged at 3000 rcf for 5 minutes below 10°C to separate plasma. For precaution purpose, the blood samples will be kept in ice cold water bath before centrifugation and during separation. The separated plasma will be transferred to pre-labeled polypropylene tubes and stored upright in a box containing dry ice or in a freezer at a temperature -65 ± 10 °C for interim storage as required.
Finally the samples will be transferred by keeping them in a box containing dry ice and stored in a bioanalytical freezer at -65 ± 10 °C until completion of analysis at Synergia Life Sciences Pvt. Ltd.
The concentration of vitamin K2-7 will be measured at Synergia Life Sciences Pvt. Ltd. using single Fluorescence HPLC method, which is validated according to the international guidelines. Literature data of vitamin K2-7 will be used for comparison in view of complete paucity of Indian data on plasma levels of Vitamin K2-7.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 28.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female aged 28 to 45 healthy subjects.
- •Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg / height in sq.m. Willing to give informed consent.
排除标准
- •People who are suffering from any systemic illness.
- •People who are on corticosteroids and oral contraceptives.
- •People on antibiotics within last week People with seropositive status.
- •Pregnancy and lactating women Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
- •People who are on coumarin analogues or Quinine Hydrochloride.
- •People who have history of smoking, history of alcohol.
- •substance abuse, within last week.
结局指标
主要结局
The primary objective is to study the levels of Vitamin K2-7 in healthy volunteers
时间窗: 1 day
次要结局
- Vitamin K2-7 levels(1 day)