Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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:
|
|
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:
|
|
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:
|
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 |
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| India | |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences | |
| Lucknow, Uttar Pradesh, India, 226014 | |
| Principal Investigator: | Eesh Bhatia, MD | Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India |
More Information
Publications:
| 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 Calcinosis Pancreatic Diseases Digestive System Diseases Calcium Metabolism Disorders Metabolic 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 May 23, 2013