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

February 10, 2013 updated by: Eesh Bhatia, Sanjay Gandhi Postgraduate Institute of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
IM Vitamin D3 3,00,000 Units single dose
Drug: Vitamin D3 (Cholecalciferol)

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

Other Names:
  • IM vitamin D3 - Inj Arachitol (Solvay, India)
  • Oral vitamin D3 - Tab Cipcal (Cipla, India)
Active Comparator: Group B
IM vitamin D3 6,00,000 Units single dose
Drug: Vitamin D3 (Cholecalciferol)

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

Other Names:
  • IM vitamin D3 - Inj Arachitol (Solvay, India)
  • Oral vitamin D3 - Tab Cipcal (Cipla, India)
Active Comparator: Group C
Oral vitamin D3 500 Units/ day
Drug: Vitamin D3 (Cholecalciferol)

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

Other Names:
  • IM vitamin D3 - Inj Arachitol (Solvay, India)
  • Oral vitamin D3 - Tab Cipcal (Cipla, India)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml
Time Frame: 6 months post intervention
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
Time Frame: 0, 1, 3, 6 months post intervention
Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months
0, 1, 3, 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Investigators

  • Principal Investigator: Eesh Bhatia, MD, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

February 10, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGI/AA/EMP/IEC/46/25.7.09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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