The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis
研究概览
简要总结
Acute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency.
Recently, the investigators and others have found that vitamin D may protect from the formation of fibrosis on cellular level. The investigators hypothesized that after the first AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and designed this RCT.
The aim is to study whether the investigators can prevent CP with vitamin D substitute.
In this randomized controlled patient study, the patients after their first AP are randomized to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin D substitute daily. The patients are examined by MRI/MRCP imaging and laboratory tests at the baseline after recovery from AP and yearly then after.
Primary endpoint is the development of parenchymal changes possibly related to fibrosis. Secondary endpoints are the development of CP with Mannheim criteria, CP related complications and mortality.
The first analysis will be done after 7 years.
The enrollment will begin 26.9.2016
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First alcohol induced acute pancreatitis
- •Willing to participate in a 3 year RCT
排除标准
- •Renal failure
- •Hypercalcemia
- •High serum levels of vitamin D
- •Unwilling to participate
结局指标
主要结局
The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis
时间窗: 3 years
A radiologist analyses the pancreatic parenchymal changes from MRCP images
次要结局
- The development of complications related to chronic pancreatitis(3 years)
- The development of chronic pancreatitis (CP) with Mannheim criteria(3 years)
- Mortality related to chronic pancreatitis(3 years)
研究者
Mikael Parhiala
PhD canditate
Tampere University Hospital