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临床试验/NCT01609387
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

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

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Homan

Investigator

Rijnstate Hospital

研究点 (2)

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