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

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ClinicalTrials.gov Identifier: NCT00956839
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Eesh Bhatia, Sanjay Gandhi Postgraduate Institute of Medical Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pancreatitis, Chronic
Intervention Drug: Vitamin D3 (Cholecalciferol)
Enrollment 40
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.
Arm/Group Title IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3
Hide Arm/Group Description IM Vitamin D3 3,00,000 Units single dose IM vitamin D3 6,00,000 Units single dose Oral vitamin D3 500 Units/ day
Period Title: Overall Study
Started 14 13 13
Completed 11 13 10
Not Completed 3 0 3
Reason Not Completed
Lost to Follow-up             3             0             3
Arm/Group Title IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3 Total
Hide Arm/Group Description IM Vitamin D3 3,00,000 Units single dose IM vitamin D3 6,00,000 Units single dose Oral vitamin D3 500 Units/ day Total of all reporting groups
Overall Number of Baseline Participants 14 13 13 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 13 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
13
 100.0%
13
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 13 participants 40 participants
30.3  (8.9) 33.9  (10.6) 34.3  (9.2) 33  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 13 participants 40 participants
Female
6
  42.9%
3
  23.1%
5
  38.5%
14
  35.0%
Male
8
  57.1%
10
  76.9%
8
  61.5%
26
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 14 participants 13 participants 13 participants 40 participants
14 13 13 40
1.Primary Outcome
Title Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml
Hide Description Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml
Time Frame 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3
Hide Arm/Group Description:
IM Vitamin D3 3,00,000 Units single dose
IM vitamin D3 6,00,000 Units single dose
Oral vitamin D3 500 Units/ day
Overall Number of Participants Analyzed 14 13 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
85
(75.1 to 94.9)
29
(16.9 to 41.1)
0
(0 to 0)
2.Secondary Outcome
Title Serum Total Calcium
Hide Description Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months
Time Frame 0, 1, 3, 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
at time points 0, 1, 3 and 6 months
Arm/Group Title IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3
Hide Arm/Group Description:
IM Vitamin D3 3,00,000 Units single dose
IM vitamin D3 6,00,000 Units single dose
Oral vitamin D3 500 Units/ day
Overall Number of Participants Analyzed 14 13 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
baseline 9.20  (0.48) 9.56  (0.48) 9.24  (0.48)
1 month 9.28  (0.44) 9.52  (0.40) 9.28  (0.52)
3 months 9.40  (0.52) 9.44  (0.48) 9.40  (0.52)
6 months 9.40  (0.60) 9.40  (0.60) 9.28  (0.48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3
Hide Arm/Group Description IM Vitamin D3 3,00,000 Units single dose IM vitamin D3 6,00,000 Units single dose Oral vitamin D3 500 Units/ day
All-Cause Mortality
IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IM Vitamin D3 3,00,000 Units IM Vitamin D3 6,00,000 Units Oral Vitamin D3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Eesh Bhatia
Organization: Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
Phone: 00915222494382
EMail: ebhatia@sgpgi.ac.in
Publications:
Layout table for additonal information
Responsible Party: Eesh Bhatia, Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00956839     History of Changes
Other Study ID Numbers: PGI/AA/EMP/IEC/46/25.7.09
First Submitted: August 10, 2009
First Posted: August 11, 2009
Results First Submitted: July 23, 2012
Results First Posted: March 14, 2013
Last Update Posted: March 14, 2013