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Pancreatitis, ChronicPhase 4NCT00956839

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

A Phase 4 study testing Vitamin D3 (Cholecalciferol) in people with Pancreatitis, Chronic, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Pancreatitis, Chronic
What is being tested?
Vitamin D3 (Cholecalciferol)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndia
Study dates
Jul 2009to Dec 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226014

Other trials in India

About this study

Official title: Double-blind Randomized Study to Determine the Efficacy of Intramuscular Vitamin D3 Supplementation in Tropical Calcific Pancreatitis

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.

Read the 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.

Being tested
Vitamin D3 (Cholecalciferol)
Keywords
Tropical calcific pancreatitis, Tropical chronic pancreatitis, Chronic pancreatitis, Vitamin D, Vitamin D deficiency, Cholecalciferol, Intramuscular vitamin D3
Medical subject headings
Pancreatitis, Chronic, Tropical Calcific Pancreatitis, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3 (Cholecalciferol)Drug

    Also called IM vitamin D3 - Inj Arachitol (Solvay, India), Oral vitamin D3 - Tab Cipcal (Cipla, India)

    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

Study groups in NCT00956839
Study groupRoleWhat they receive
Group AActive comparatorIM Vitamin D3 3,00,000 Units single dose
Receives: Drug: Vitamin D3 (Cholecalciferol)
Group BActive comparatorIM vitamin D3 6,00,000 Units single dose
Receives: Drug: Vitamin D3 (Cholecalciferol)
Group CActive comparatorOral vitamin D3 500 Units/ day
Receives: Drug: Vitamin D3 (Cholecalciferol)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months post intervention

Secondary outcomes (1)

  1. Serum Total Calcium

    Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months

    Measured: 0, 1, 3, 6 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00956839
Sponsor's protocol ID
PGI/AA/EMP/IEC/46/25.7.09
Status last verified
Feb 2013
First submitted
10 Aug 2009
Last updated
14 Mar 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 12757166

  • 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.

    PubMed 14654569

  • 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.

    PubMed 18824882

  • 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.

    PubMed 15613415

  • 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.

    PubMed 15860755

  • 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.

    PubMed 18589445

  • 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.

    PubMed 11237938

  • 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.

    PubMed 15992330

  • 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.

    PubMed 10232622

  • 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.

    PubMed 23564348

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D3 (Cholecalciferol) in people with Pancreatitis, Chronic, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml (time frame: 6 months post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00956839, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.

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