Vitamin Deficiencies and Suppletion in Morbid Obesity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- reduction in patients with vitamin B12 deficiency
研究概览
简要总结
The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.
详细描述
Vitamin B12 deficiency accounts up to 23-64% bariatric surgery. The investigators purpose is to evaluate the most effective treatment for vitamin B12 deficiency in patients who underwent a Roux-en-Y gastric bypass.
Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.
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 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Vitamin B12 deficiency: <200 pmol/l
- •Vitamin B12 deficiency 6-12 months after surgery
- •All patients underwent a Roux-en-Y gastric bypass
排除标准
- •Creatin >150micromol/L
- •Liver enzymes >2 times upper limit
- •Other bariatric operations
- •Intercurrent diseases
- •Gastro-intestinal diseases
- •Psychiatric disease
- •Medicines which influences bone density
研究组 & 干预措施
hydroxocobalamin injection
25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection
干预措施: Hydroxocobalamin (Drug)
FitForMe vitamin B12 tablets
25 patients receive a daily dose vitamine B12 tablets
干预措施: FitForMe vitamin B12 (Drug)
结局指标
主要结局
reduction in patients with vitamin B12 deficiency
时间窗: 6 months after initiating therapy
Before starting treatment vitamin B12, homocystein and methylmalonic acid will be measured. Two and 4 months after starting treatment vitamine B12 levels will be measured. At 6 months after initiating therapy again vitamin B12, homocystein and methylmalonic acid will be measured.
次要结局
未报告次要终点