The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis

Tampere University Hospital

Status: Completed

Conditions: Chronic Pancreatitis

Treatments: Dietary Supplement: Vitamin D 10ug; Dietary Supplement: Vitamin D 100ug

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02965898

R16004

Details and patient eligibility

About

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

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 101 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First alcohol induced acute pancreatitis
• Willing to participate in a 3 year RCT

Exclusion criteria

• Renal failure
• Hypercalcemia
• High serum levels of vitamin D
• Unwilling to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

260 participants in 2 patient groups, including a placebo group

Vitamin D 100ug

Active Comparator group

Description:

The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.

Treatment:

Dietary Supplement: Vitamin D 100ug

Vitamin D 10ug

Placebo Comparator group

Description:

Placebo dose. Minimal recommended dose

Treatment:

Dietary Supplement: Vitamin D 10ug