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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eesh Bhatia, Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00956839
First received: August 10, 2009
Last updated: February 10, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Pancreatitis, Chronic
Drug: Vitamin D3 (Cholecalciferol)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Study to Determine the Efficacy of Intramuscular Vitamin D3 Supplementation in Tropical Calcific Pancreatitis

Resource links provided by NLM:


Further study details as provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:

Primary Outcome Measures:
  • Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml


Secondary Outcome Measures:
  • Serum Total Calcium [ Time Frame: 0, 1, 3, 6 months post intervention ] [ Designated as safety issue: Yes ]
    Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months


Enrollment: 40
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956839

Locations
India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
Sponsors and Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Investigators
Principal Investigator: Eesh Bhatia, MD Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eesh Bhatia, Doctor, Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00956839     History of Changes
Other Study ID Numbers: PGI/AA/EMP/IEC/46/25.7.09
Study First Received: August 10, 2009
Results First Received: July 23, 2012
Last Updated: February 10, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Tropical calcific pancreatitis
Tropical chronic pancreatitis
Chronic pancreatitis
Vitamin D
Vitamin D deficiency
Cholecalciferol
Intramuscular vitamin D3

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 28, 2014