Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | IM Vitamin D3 3,00,000 Units single dose |
|
| Group B | Active Comparator | IM vitamin D3 6,00,000 Units single dose |
|
| Group C | Active Comparator | Oral vitamin D3 500 Units/ day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (Cholecalciferol) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Total Calcium | Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months | 0, 1, 3, 6 months post intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eesh Bhatia, MD | Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | Uttar Pradesh | 226014 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12757166 | Background | Mann ST, Stracke H, Lange U, Klor HU, Teichmann J. Vitamin D3 in patients with various grades of chronic pancreatitis, according to morphological and functional criteria of the pancreas. Dig Dis Sci. 2003 Mar;48(3):533-8. doi: 10.1023/a:1022540816990. | |
| 14654569 | Background | Barman KK, Premalatha G, Mohan V. Tropical chronic pancreatitis. Postgrad Med J. 2003 Nov;79(937):606-15. doi: 10.1136/pmj.79.937.606. |
Not provided
Not provided
All patients who consented for the study were enrolled and randomized.
Patients were recruited from Endocrinology and Gastroenterology Clinics of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow from July 2009 to December 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IM Vitamin D3 3,00,000 Units | IM Vitamin D3 3,00,000 Units single dose |
| FG001 | IM Vitamin D3 6,00,000 Units | IM vitamin D3 6,00,000 Units single dose |
| FG002 | Oral Vitamin D3 | Oral vitamin D3 500 Units/ day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IM Vitamin D3 3,00,000 Units | IM Vitamin D3 3,00,000 Units single dose |
| BG001 | IM Vitamin D3 6,00,000 Units | IM vitamin D3 6,00,000 Units single dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intention to treat analysis | Posted | Number | 95% Confidence Interval | percentage of patients | 6 months post intervention |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IM Vitamin D3 3,00,000 Units | IM Vitamin D3 3,00,000 Units single dose |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Eesh Bhatia | Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow | 00915222494382 | ebhatia@sgpgi.ac.in |
Not provided
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| C564276 | Tropical Calcific Pancreatitis |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 18824882 | Background | Dujsikova H, Dite P, Tomandl J, Sevcikova A, Precechtelova M. Occurrence of metabolic osteopathy in patients with chronic pancreatitis. Pancreatology. 2008;8(6):583-6. doi: 10.1159/000159845. Epub 2008 Sep 29. |
| 15613415 | Background | Aris RM, Merkel PA, Bachrach LK, Borowitz DS, Boyle MP, Elkin SL, Guise TA, Hardin DS, Haworth CS, Holick MF, Joseph PM, O'Brien K, Tullis E, Watts NB, White TB. Guide to bone health and disease in cystic fibrosis. J Clin Endocrinol Metab. 2005 Mar;90(3):1888-96. doi: 10.1210/jc.2004-1629. Epub 2004 Dec 21. |
| 15860755 | Background | Boyle MP, Noschese ML, Watts SL, Davis ME, Stenner SE, Lechtzin N. Failure of high-dose ergocalciferol to correct vitamin D deficiency in adults with cystic fibrosis. Am J Respir Crit Care Med. 2005 Jul 15;172(2):212-7. doi: 10.1164/rccm.200403-387OC. Epub 2005 Apr 28. |
| 18589445 | Background | Green D, Carson K, Leonard A, Davis JE, Rosenstein B, Zeitlin P, Mogayzel P Jr. Current treatment recommendations for correcting vitamin D deficiency in pediatric patients with cystic fibrosis are inadequate. J Pediatr. 2008 Oct;153(4):554-9. doi: 10.1016/j.jpeds.2008.04.058. Epub 2008 Jun 27. |
| 11237938 | Background | Lark RK, Lester GE, Ontjes DA, Blackwood AD, Hollis BW, Hensler MM, Aris RM. Diminished and erratic absorption of ergocalciferol in adult cystic fibrosis patients. Am J Clin Nutr. 2001 Mar;73(3):602-6. doi: 10.1093/ajcn/73.3.602. |
| 15992330 | Background | Diamond TH, Ho KW, Rohl PG, Meerkin M. Annual intramuscular injection of a megadose of cholecalciferol for treatment of vitamin D deficiency: efficacy and safety data. Med J Aust. 2005 Jul 4;183(1):10-2. doi: 10.5694/j.1326-5377.2005.tb06879.x. |
| 10232622 | Background | Vieth R. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. Am J Clin Nutr. 1999 May;69(5):842-56. doi: 10.1093/ajcn/69.5.842. |
| 23564348 | Derived | Reddy SV, Ramesh V, Bhatia E. Double blind randomized control study of intramuscular vitamin D3 supplementation in tropical calcific pancreatitis. Calcif Tissue Int. 2013 Jul;93(1):48-54. doi: 10.1007/s00223-013-9726-6. Epub 2013 Apr 6. |
| BG002 | Oral Vitamin D3 | Oral vitamin D3 500 Units/ day |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Oral vitamin D3 500 Units/ day |
|
|
| Secondary | Serum Total Calcium | Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months | at time points 0, 1, 3 and 6 months | Posted | Mean | Standard Deviation | mg/dL | 0, 1, 3, 6 months post intervention |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | IM Vitamin D3 6,00,000 Units | IM vitamin D3 6,00,000 Units single dose | 0 | 13 | 0 | 13 |
| EG002 | Oral Vitamin D3 | Oral vitamin D3 500 Units/ day | 0 | 13 | 0 | 13 |
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| 1 month |
|
| 3 months |
|
| 6 months |
|