Postoperative Vitamin Supplementation in Morbidly Obese Patient
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
- 1
- 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
研究组 & 干预措施
Gastric Banding new vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
干预措施: Fit For me (Dietary Supplement)
Gastric Banding current vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
干预措施: Davitamon (Dietary Supplement)
RYGB new vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients
干预措施: Fit For me (Dietary Supplement)
RYGB current vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients)
干预措施: Davitamon (Dietary Supplement)
Gastric sleeve new vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
干预措施: Fit For me (Dietary Supplement)
Gastric sleeve current vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
干预措施: Davitamon (Dietary Supplement)
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