NCT00956839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 14, 2013

Completed
Last Updated

March 14, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

August 10, 2009

Results QC Date

July 23, 2012

Last Update Submit

February 10, 2013

Conditions

Pancreatitis, Chronic

Keywords

Tropical calcific pancreatitisTropical chronic pancreatitisChronic pancreatitisVitamin DVitamin D deficiencyCholecalciferolIntramuscular vitamin D3

Outcome Measures

Primary Outcomes (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

    6 months post intervention

Secondary Outcomes (1)

  • Serum Total Calcium

    0, 1, 3, 6 months post intervention

Study Arms (3)

Group A

ACTIVE COMPARATOR

IM Vitamin D3 3,00,000 Units single dose

Drug: Vitamin D3 (Cholecalciferol)

Group B

ACTIVE COMPARATOR

IM vitamin D3 6,00,000 Units single dose

Drug: Vitamin D3 (Cholecalciferol)

Group C

ACTIVE COMPARATOR

Oral vitamin D3 500 Units/ day

Drug: Vitamin D3 (Cholecalciferol)

Interventions

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

Also known as: IM vitamin D3 - Inj Arachitol (Solvay, India), Oral vitamin D3 - Tab Cipcal (Cipla, India)
Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (10)

  • 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.

    PMID: 12757166BACKGROUND

  • 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.

    PMID: 14654569BACKGROUND

  • 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.

    PMID: 18824882BACKGROUND

  • 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.

    PMID: 15613415BACKGROUND

  • 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.

    PMID: 15860755BACKGROUND

  • 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.

    PMID: 18589445BACKGROUND

  • 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.

    PMID: 11237938BACKGROUND

  • 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.

    PMID: 15992330BACKGROUND

  • 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.

    PMID: 10232622BACKGROUND

  • 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.

    PMID: 23564348DERIVED

MeSH Terms

Conditions

Pancreatitis, ChronicTropical Calcific PancreatitisVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Professor Eesh Bhatia
Organization
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
ebhatia@sgpgi.ac.in
00915222494382

Study Officials

  • Eesh Bhatia, MD

    Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

March 14, 2013

Results First Posted

March 14, 2013

Record last verified: 2013-02

Locations

IN(1)