The effects of vitamin D and pancreatic enzyme replacement therapy on improving serum vitamin D levels and bone metabolism in patients with chronic pancreatitis

A Multicenter Randomized Clinical Trial to Confirm the Effect of Combined Vitamin D and Pancreatic Enzyme Supplementation Therapy on Improving Serum Vitamin D Level and Bone Metabolism in Patients with Chronic Pancreatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0009935

Enrollment

Registered

2024-11-22

Start date

2024-11-01

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Drug Administration Plan: Control Group: Nozyme 25000 tid Test Group: Nozyme 25000 IU tid, Vitamin D3 50000 IU Drugs and Dosage Regimen: Nozyme 25000 IU tid for 14 weeks Vitamin D3 50000 IU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients aged 18 years or older ? Patients diagnosed with chronic pancreatitis i. The definition of chronic pancreatitis follows the M-ANNHEIM diagnostic criteria (PMID: 17351799) ? Patients with pancreatic exocrine insufficiency i. The presence of PEI is determined by the clinician based on fecal elastase test results and clinical symptoms (PMID: 24259956) ? Patients with serum 25OH vitamin D levels lower than normal i. Lower than 30 ng/ml (PMID: 22323766)

Exclusion criteria

Exclusion criteria: ? Those from whom consent cannot be obtained ? Patients currently undergoing PERT ? Patients without confirmed PEI ? Those taking medication for osteopenia or osteoporosis, including vitamin D supplementation ? Those with a history of allergic reactions to vitamin D or pancreatic enzyme preparations ? Patients with CKD Grade 4 or higher renal dysfunction (GFR < 30 mL/min/1.73m2) ? Patients taking thiazide diuretics ? Patients with kidney stones or nephrocalcinosis ? Patients with confirmed hypercalcemia or conditions that cause hypercalcemia (e.g., multiple myeloma, bone metastases or other malignant bone diseases, primary hyperparathyroidism, sarcoidosis or other granulomatous diseases) ? Those with a history of drug abuse ? Patients under 18 years of age"

Design outcomes

Primary

Measure	Time frame
serum 25(OH) vit D level change	—

Secondary

Measure	Time frame
bone turnover marker change;bone density change;fracture occurrence;adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactJin Ho Choi

Seoul National University Hospital

pseudo.jh@gmail.com+82-2-2072-1474

Outcome results