Phase 4
Completed N=40
Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
Pancreatitis, Chronic
Source: ClinicalTrials.gov NCT00956839 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml — 85; 29; 0 percentage of patients
Summary
The purpose of this study is to determine the efficacy of 2 different doses of intramuscular (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in the blood of patients with tropical calcific pancreatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml |
85; 29; 0 | — |
| SECONDARY Serum Total Calcium |
9.20; 9.56; 9.24; 9.28; 9.52; 9.28 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of tropical calcific pancreatitis established by history of abdominal pain or diabetes and evidence on ultrasound or CT scan of pancreatic ductal dilatation and intra-ductal stones
Exclusion Criteria
- History of alcohol intake or any secondary cause for chronic pancreatitis (hypercalcemia, hypertriglyceridemia, biliary tract stones)
- History of hepatic or renal dysfunction or of current intake of drugs such as steroids, anticonvulsant drugs
Data sourced from ClinicalTrials.gov (NCT00956839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.