Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- normal value serum ferritin
研究概览
简要总结
Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.
详细描述
Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.
Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.
Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all women who underwent a Roux-en-Y gastric bypass and developed an iron deficiency postoperatively (ferritin<20microgram/L)
排除标准
- •iron deficiency peroperative, blood transfusions during study period, iron containing nutritional supplements except the standard multivitamins after bariatric surgery, decreased renal failure, excessive blood loss due to menstruation, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for noe of the medicinal products, psychiatric illness, pregnancy
研究组 & 干预措施
Iron(III)carboxymaltose
40 patients receive a single intravenous shot of ferinject
干预措施: Iron(III)carboxymaltose (Drug)
Ferrous fumarate
40 patients receive ferrous fumarate 3 times a day 200mg
干预措施: Ferrous fumarate (Drug)
Ferrous gluconate
40 patients receive ferrous gluconate 2 times a day 695 mg
干预措施: Ferrous gluconate (Drug)
结局指标
主要结局
normal value serum ferritin
时间窗: 1 year
1 year after initiating therapy
次要结局
- patients preference for oral or intravenous therapy(1 year)