CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 260 target
Drug / intervention
Vitamin D 100ug +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02965898
NCT02965898N/ACompleted

The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial

Tampere University Hospital·interventional·Posted Nov 17, 2016·Updated Apr 16, 2025

In Brief

A clinical study evaluating Vitamin D 100ug and Vitamin D 10ug for Chronic Pancreatitis. Completed, enrolled 260 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 17, 2016
Enrollment StartSep 1, 2016
Primary CompletionMar 10, 2024
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 9.6 years ago

Interventions

Vitamin D 100ugdietary

Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.

Vitamin D 10ugdietary

Placebo dose. Minimal recommended dose.