Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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Tropical calcific pancreatitis (TCP) is a form of chronic pancreatitis unique to developing countries. Patients with TCP often have malabsorption leading to nutritional deficiencies. We have noted that vitamin D deficiency is common in patients with TCP. The ideal regimen for supplementing vitamin D3 in chronic pancreatitis remains unclear and there are no previous studies available. High dose oral vitamin D2 has been shown to be ineffective in normalizing vitamin D levels in patients with pancreatic insufficiency due to cystic fibrosis. Intramuscular (IM) vitamin D3 supplementation in chronic pancreatitis has certain advantages. Firstly, decreased and inconsistent absorption from the intestine is avoided. Secondly, IM vitamin D3 has a long duration of action (6-12 months). The safety of high-dose IM vitamin D3 has been proven in previous studies in healthy individuals. Finally, the injection form is considerably less expensive as compared to oral vitamin D3. The aim of the current prospective double blind study is to compare 2 regimens of high dose IM vitamin D3 replenishment with oral vitamin D3 in standard recommended doses in normalizing serum vitamin D3 levels in patients with TCP.

Official Title
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Double-blind Randomized Study to Determine the Efficacy of Intramuscular Vitamin D3 Supplementation in Tropical Calcific Pancreatitis

Conditions
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Pancreatitis, Chronic

Intervention / Treatment
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* Drug: Vitamin D3 (Cholecalciferol)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>IM Vitamin D3 3,00,000 Units single dose | Drug: Vitamin D3 (Cholecalciferol)<br>* Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose Arm 3 - Oral vitamin D3 500 Units/day for 6 months<br>* Other names: Oral vitamin D3 - Tab Cipcal (Cipla, India);|
| Active Comparator: Group B<br>IM vitamin D3 6,00,000 Units single dose | Drug: Vitamin D3 (Cholecalciferol)<br>* Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose Arm 3 - Oral vitamin D3 500 Units/day for 6 months<br>* Other names: Oral vitamin D3 - Tab Cipcal (Cipla, India);|
| Active Comparator: Group C<br>Oral vitamin D3 500 Units/ day | Drug: Vitamin D3 (Cholecalciferol)<br>* Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose Arm 3 - Oral vitamin D3 500 Units/day for 6 months<br>* Other names: Oral vitamin D3 - Tab Cipcal (Cipla, India);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml | Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml | 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Total Calcium | Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months | 0, 1, 3, 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tropical calcific pancreatitis, Tropical chronic pancreatitis, Chronic pancreatitis, Vitamin D, Vitamin D deficiency, Cholecalciferol, Intramuscular vitamin D3