Trial Outcomes & Findings for Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis (NCT NCT00956839)
NCT ID: NCT00956839
Last Updated: 2013-03-14
Results Overview
Percentage of patients in each group with serum 25 hydroxy vitamin D \>30 ng/ml
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
6 months post intervention
Results posted on
2013-03-14
Participant Flow
Patients were recruited from Endocrinology and Gastroenterology Clinics of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow from July 2009 to December 2009
All patients who consented for the study were enrolled and randomized.
Participant milestones
| Measure |
IM Vitamin D3 3,00,000 Units
IM Vitamin D3 3,00,000 Units single dose
|
IM Vitamin D3 6,00,000 Units
IM vitamin D3 6,00,000 Units single dose
|
Oral Vitamin D3
Oral vitamin D3 500 Units/ day
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
13
|
|
Overall Study
COMPLETED
|
11
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
3
|
Reasons for withdrawal
| Measure |
IM Vitamin D3 3,00,000 Units
IM Vitamin D3 3,00,000 Units single dose
|
IM Vitamin D3 6,00,000 Units
IM vitamin D3 6,00,000 Units single dose
|
Oral Vitamin D3
Oral vitamin D3 500 Units/ day
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
3
|
Baseline Characteristics
Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
Baseline characteristics by cohort
| Measure |
IM Vitamin D3 3,00,000 Units
n=14 Participants
IM Vitamin D3 3,00,000 Units single dose
|
IM Vitamin D3 6,00,000 Units
n=13 Participants
IM vitamin D3 6,00,000 Units single dose
|
Oral Vitamin D3
n=13 Participants
Oral vitamin D3 500 Units/ day
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
30.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
33 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
40 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months post interventionPopulation: Intention to treat analysis
Percentage of patients in each group with serum 25 hydroxy vitamin D \>30 ng/ml
Outcome measures
| Measure |
IM Vitamin D3 3,00,000 Units
n=14 Participants
IM Vitamin D3 3,00,000 Units single dose
|
IM Vitamin D3 6,00,000 Units
n=13 Participants
IM vitamin D3 6,00,000 Units single dose
|
Oral Vitamin D3
n=13 Participants
Oral vitamin D3 500 Units/ day
|
|---|---|---|---|
|
Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml
|
85 percentage of patients
Interval 75.1 to 94.9
|
29 percentage of patients
Interval 16.9 to 41.1
|
0 percentage of patients
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 0, 1, 3, 6 months post interventionPopulation: at time points 0, 1, 3 and 6 months
Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months
Outcome measures
| Measure |
IM Vitamin D3 3,00,000 Units
n=14 Participants
IM Vitamin D3 3,00,000 Units single dose
|
IM Vitamin D3 6,00,000 Units
n=13 Participants
IM vitamin D3 6,00,000 Units single dose
|
Oral Vitamin D3
n=13 Participants
Oral vitamin D3 500 Units/ day
|
|---|---|---|---|
|
Serum Total Calcium
3 months
|
9.40 mg/dL
Standard Deviation 0.52
|
9.44 mg/dL
Standard Deviation 0.48
|
9.40 mg/dL
Standard Deviation 0.52
|
|
Serum Total Calcium
baseline
|
9.20 mg/dL
Standard Deviation 0.48 • Interval 0.0 to 0.0
|
9.56 mg/dL
Standard Deviation 0.48 • Interval 0.0 to 0.0
|
9.24 mg/dL
Standard Deviation 0.48 • Interval 0.0 to 0.0
|
|
Serum Total Calcium
1 month
|
9.28 mg/dL
Standard Deviation 0.44
|
9.52 mg/dL
Standard Deviation 0.40
|
9.28 mg/dL
Standard Deviation 0.52
|
|
Serum Total Calcium
6 months
|
9.40 mg/dL
Standard Deviation 0.60
|
9.40 mg/dL
Standard Deviation 0.60
|
9.28 mg/dL
Standard Deviation 0.48
|
Adverse Events
IM Vitamin D3 3,00,000 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IM Vitamin D3 6,00,000 Units
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Vitamin D3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Eesh Bhatia
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
Phone: 00915222494382
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place