Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
NCT ID: NCT00956839
Last Updated: 2013-03-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2009-07-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
NCT00985361
Effects of 5-Aminolevulinic Acid on Glucose Metabolism
NCT01610778
Role of Alpha-lipoic Acid in Diabetes Melitus Type 1
NCT05679037
Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes
NCT06920667
Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes
NCT05271045
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
IM Vitamin D3 3,00,000 Units single dose
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
Group B
IM vitamin D3 6,00,000 Units single dose
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
Group C
Oral vitamin D3 500 Units/ day
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* History of hepatic or renal dysfunction or of current intake of drugs such as steroids, anticonvulsant drugs
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanjay Gandhi Postgraduate Institute of Medical Sciences
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eesh Bhatia
Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eesh Bhatia, MD
Role: PRINCIPAL_INVESTIGATOR
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PGI/AA/EMP/IEC/46/25.7.09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.