Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Comparison of pharmacokinetic parameters
研究概览
简要总结
Set the pattern of vitamin D supplementation in obese patients undergoing bariatric surgery in deficit of vitamin D.
Patients receive a single oral dose of vitamin D, during the 28 days will be done a kinetic curve. Then and over the next 3 months, levels are normalized. Once normalized, will be administered another single oral dose to a second pharmacokinetic evaluation.
详细描述
The study is conducted in obese patients undergoing bariatric surgery (for bypass or sleeve gastrectomy) in deficit of vitamin D.
Will include a total of 44 patients, 22 from each type of surgery. Patients receive a single oral dose of vitamin D of 50,000 IU. During the 28 days after administration of vitamin D will be done a kinetic curve determining plasma levels of vitamin D on 15 occasions. Then and over the next 3 months, levels are normalized by providing a daily oral dose for each patient. Once levels are normalized, will be administered another single oral dose of 50,000 IU vitamin D and proceed to a second pharmacokinetic evaluation determining plasma levels 15 times.
Patient follow up is approximately 36 weeks. Patients go to the screening visit, baseline visit and visits on days 1, 2, 3, 14 and 28 days after each pharmacokinetic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 or more years old
- •with bariatric surgery in the last 18 months (+/- 6 months)
- •BMI: 25-33 kg/m2
- •vitamin D3 (OK)<20ng/mL.
- •Clinically stable, in the opinion of the investigator, at the time of inclusion
- •Signed consent form
排除标准
- •pregnancy, lactation or intention during the study period.
- •menopause
- •GOP, GPT>2 UNL
- •glomerular filtration rate <60ml/min
- •previous renal lithiasis
- •any digestive disease to suggest malabsorption, granulomatous diseases, diabetic gastroenteropathy and taking medication likely to interfere with the absorption of vitamin D and bone metabolism such as corticosteroids and anticonvulsants
- •taking medication that interferes with calcium metabolism.
- •cholecalciferol hypersensitivity.
- •other bariatric surgery (different of by-pass or tubular gastrectomy)
研究组 & 干预措施
Cholecalciferol
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Comparison of pharmacokinetic parameters
时间窗: 36 weeks
Comparison of the pharmacokinetic parameters of vitamin D according to a non compartimental approach (AUC0-t, AUC0-∞, Cmax and t1/2) between a state of vitamin D and after normalization of the same.
次要结局
- Comparison of the pharmacokinetic parameters between the two types of surgery(36 weeks)
- Proportion of patients with secondary hyperparathyroidism in both surgeries.(36 weeks)
- Change from baseline levels of urinary excretion of calcium in both surgeries(36 weeks)
- Change from baseline levels of urinary excretion creatinine in both surgeries(36 weeks)
- Change from baseline in both biochemistry surgery(36 weeks)
- Change from baseline alkaline phosphatase levels in both surgeries(36 weeks)
- Change from baseline body fat distribution by DEXA(36 weeks)
- Changes adherence in both surgeries(36 weeks)
- Incidence of adverse and clinical laboratory events for each of the surgeries(36 weeks)
- Proportion of patients with serious adverse events related to medication(36 weeks)