High-Dose Vitamin D and Early Chronic Pancreatitis-Related Changes After Acute Pancreatitis: A Randomized Dose Controlled Trial
摘要
Chronic pancreatitis (CP) is an irreversible condition with multiple comorbidities. Pancreatic stellate cells (PCSs) are crucial in the fibrotic process in CP. PSCs have a regulating vitamin D receptor. The aim was to assess if a daily higher dose of vitamin D can prevent the progression to CP in patients after the first episode of acute pancreatitis (AP).
MethodsThis was a single-centre randomized placebo -controlled trial. Patients were randomized after the first episode of AP to either a daily 100 µg high-dose vitamin D (HDVD) or a 10 µg low-dose vitamin D (LDVD) groups. Follow-up included magnetic resonance imaging (MRI), laboratory tests and QoL questionnaires (QLQ-C30 and Pan26). The development of parenchymal changes possibly related to fibrosis after AP in MRI.
ResultsSixty-nine patients were recruited. There was a high dropout (51%), therefore the final analysis included all patients who completed the three or two years of trial: in total 34 patients. No definitive CP cases occurred in HDVD group, while one was observed in LDVD group (p = 0.367). Less CP related findings developed during the trial in the HDVD compared to the LDVD group (n = 4 vs n = 13, p = 0.016). The HDVD patients had a significantly lower pain score than the LDVD group (p = 0.019). Vitamin D levels were significantly higher in HDVD group compared to LDVD group without adverse effects.
ConclusionsHDVD after AP was linked to fewer early CP-related changes during 2–3 years of follow-up. These preliminary findings warrant confirmation in larger trials with longer observation. Long-term interventional trials are challenging in this patient group.
Trial registration number: ClinicalTrials.gov: NCT02965898.