Maintenance of Multivitamin Supplements After Sleeve Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Iron serum levels
研究概览
简要总结
A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.
详细描述
A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement (Multicentrum, Pfizer, 1 tablet/day) during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins (D, B12 and folic acid) and oligoelements (calcium, iron, phosphorus, magnesium and zinc) at 3, 6 and 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing laparoscopic sleeve gastrectomy
- •BMI >40 Kg/m2
- •BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
排除标准
- •documented gastroesophageal reflux
- •patients with uncontrolled psychiatric disorders
- •active infections or malignancies
- •any other concomitant pathology considered as a contraindication for bariatric surgery.
研究组 & 干预措施
Multicentrum® 3 months
Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 3 months
干预措施: Multicentrum® (Pfizer, Spain) 3 months (Drug)
Multicentrum® 12 months
Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 12 months
干预措施: Multicentrum® (Pfizer, Spain) 12 months (Drug)
结局指标
主要结局
Iron serum levels
时间窗: 12 months
Iron serum levels will be investigated in blood samples 12 months after surgery
次要结局
- Calcium serum levels(12 months)
- Vitamin B12 serum levels(12 months)
- Folic acid serum levels(12 months)
研究者
Jaime Ruiz-Tovar, MD, PhD
MD, PhD
Hospital General Universitario Elche