How Many Patients Are in Need of Vitamin B12 Injections?
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in plasma holotranscobalamin
研究概览
简要总结
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.
The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:
- need life long injections with vitamin B12,
- only need supplementations with a small dose of oral vitamin B12, and
- no need for further vitamin B12 treatment.
The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.
详细描述
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.
The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:
- need life long injections with vitamin B12,
- only need supplementations with a small dose of oral vitamin B12, and
- no need for further vitamin B12 treatment.
The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 17 years old
- •Have received vitamin B12 treatment for at least one year
- •Capable of reading and understanding Danish
排除标准
- •Pregnant or nursing women
- •Not capable of giving informed consent
- •Acute infection during the 3-day examination of vitamin B12 absorption
结局指标
主要结局
Change in plasma holotranscobalamin
时间窗: Every month
Change in plasma cobalamins
时间窗: Every month
Change in plasma methylmalonic acid
时间窗: Every month
次要结局
未报告次要终点