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

Phase 4

Completed

• Conditions: Pancreatitis, Chronic
• Interventions: Drug: Vitamin D3 (Cholecalciferol)

• Registration Number: NCT00956839
• Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Results First Submitted: 2012-07-23
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-10
• Last Update Submitted: 2013-02-10
• Results First Posted: 2013-03-14
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Vitamin D3 (Cholecalciferol)	IM vitamin D3 6,00,000 Units single dose
Group C	Vitamin D3 (Cholecalciferol)	Oral vitamin D3 500 Units/ day
Group A	Vitamin D3 (Cholecalciferol)	IM Vitamin D3 3,00,000 Units single dose

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml	6 months post intervention	Percentage of patients in each group with serum 25 hydroxy vitamin D \>30 ng/ml

Secondary Outcome Measures

Name	Time	Method
Serum Total Calcium	0, 1, 3, 6 months post intervention	Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months

Trial Locations

Locations (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences; 🇮🇳 Lucknow, Uttar Pradesh, India