Pancreatitis, Chronic
Conditions
Keywords
Tropical calcific pancreatitis, Tropical chronic pancreatitis, Chronic pancreatitis, Vitamin D, Vitamin D deficiency, Cholecalciferol, Intramuscular vitamin D3
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.
Interventions
DRUGVitamin 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
Sponsors
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum Total Calcium | 0, 1, 3, 6 months post intervention | Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months |
Countries
India
Participant flow
Recruitment details
Patients were recruited from Endocrinology and Gastroenterology Clinics of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow from July 2009 to December 2009
Pre-assignment details
All patients who consented for the study were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| IM Vitamin D3 3,00,000 Units IM Vitamin D3 3,00,000 Units single dose | 14 |
| IM Vitamin D3 6,00,000 Units IM vitamin D3 6,00,000 Units single dose | 13 |
| Oral Vitamin D3 Oral vitamin D3 500 Units/ day | 13 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 | 3 |
Baseline characteristics
| Characteristic | IM Vitamin D3 6,00,000 Units | Oral Vitamin D3 | IM Vitamin D3 3,00,000 Units | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 13 Participants | 14 Participants | 40 Participants |
| Age Continuous | 33.9 years STANDARD_DEVIATION 10.6 | 34.3 years STANDARD_DEVIATION 9.2 | 30.3 years STANDARD_DEVIATION 8.9 | 33 years STANDARD_DEVIATION 9 |
| Region of Enrollment India | 13 participants | 13 participants | 14 participants | 40 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 8 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 13 |
Outcome results
Primary
Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml
Percentage of patients in each group with serum 25 hydroxy vitamin D \>30 ng/ml
Time frame: 6 months post intervention
Population: Intention to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IM Vitamin D3 3,00,000 Units | Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml | 85 percentage of patients |
| IM Vitamin D3 6,00,000 Units | Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml | 29 percentage of patients |
| Oral Vitamin D3 | Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml | 0 percentage of patients |
Secondary
Serum Total Calcium
Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months
Time frame: 0, 1, 3, 6 months post intervention
Population: at time points 0, 1, 3 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IM Vitamin D3 3,00,000 Units | Serum Total Calcium | 3 months | 9.40 mg/dL | Standard Deviation 0.52 |
| IM Vitamin D3 3,00,000 Units | Serum Total Calcium | 6 months | 9.40 mg/dL | Standard Deviation 0.6 |
| IM Vitamin D3 3,00,000 Units | Serum Total Calcium | baseline | 9.20 mg/dL | Standard Deviation 0.48 |
| IM Vitamin D3 3,00,000 Units | Serum Total Calcium | 1 month | 9.28 mg/dL | Standard Deviation 0.44 |
| IM Vitamin D3 6,00,000 Units | Serum Total Calcium | 3 months | 9.44 mg/dL | Standard Deviation 0.48 |
| IM Vitamin D3 6,00,000 Units | Serum Total Calcium | 1 month | 9.52 mg/dL | Standard Deviation 0.4 |
| IM Vitamin D3 6,00,000 Units | Serum Total Calcium | 6 months | 9.40 mg/dL | Standard Deviation 0.6 |
| IM Vitamin D3 6,00,000 Units | Serum Total Calcium | baseline | 9.56 mg/dL | Standard Deviation 0.48 |
| Oral Vitamin D3 | Serum Total Calcium | 6 months | 9.28 mg/dL | Standard Deviation 0.48 |
| Oral Vitamin D3 | Serum Total Calcium | baseline | 9.24 mg/dL | Standard Deviation 0.48 |
| Oral Vitamin D3 | Serum Total Calcium | 1 month | 9.28 mg/dL | Standard Deviation 0.52 |
| Oral Vitamin D3 | Serum Total Calcium | 3 months | 9.40 mg/dL | Standard Deviation 0.52 |