NCT01609387已完成4 期
Postoperative Vitamin Supplementation in Morbidly Obese Patient
Rijnstate Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Reduction of iron deficiency in obese patients
研究概览
简要总结
This study is a double blind randomized controlled trial.
详细描述
Based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and Roux-en-Y gastric bypass (RYGB). These preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. Main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin B12 and vitamin D can be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Patients on the waiting list for RYGB or gastric band and meets
- •Age between 18-65 years
排除标准
- •Creatinine > 150micromol / L
- •Liver enzymes > 2 times the upper limit
- •Previous surgery on the gastrointestinal tract
- •Intercurrerence disease
- •Gastrointestinal Diseases
- •Psychiatric illness
- •Drugs that affect bone metabolism
- •Known pregnancy
结局指标
主要结局
Reduction of iron deficiency in obese patients
时间窗: one year
次要结局
- Reduction of vitamin D and vitamin B12 deficiency(one year)
研究者
Jens Homan
Investigator
Rijnstate Hospital
研究点 (2)
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