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

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Brief Title

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

Official Title

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

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml

Secondary Outcome

 Serum Total Calcium

Condition

Pancreatitis, Chronic

Intervention

Vitamin D3 (Cholecalciferol)

Study Arms / Comparison Groups

 Group A
Description:  IM Vitamin D3 3,00,000 Units single dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

July 2009

Completion Date

December 2010

Primary Completion Date

June 2010

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
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Eesh Bhatia, MD, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT00956839

Organization ID

PGI/AA/EMP/IEC/46/25.7.09


Responsible Party

Principal Investigator

Study Sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences


Study Sponsor

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


Verification Date

February 2013