Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
Primary Purpose
Chronic Pancreatitis, Malabsorption Syndromes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calcium, Dietary
Cholecalciferol
UVB
UV-filtered light.
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Chronic pancreatitis
- Malabsorption
- Age min. 18 y.
- 25-hydroxyvitamin D less than 75 nmol/l
- Body mass index < 30
- Consent
Exclusion Criteria:
- Acute pancreatitis
- Cirrhosis
- Ionized calcium > 1.35 mmol/l
- Heart disease
- Former resection of gastro-intestinal tract.
- Pregnancy
- Pancreatic malignant disease
- History of skin cancer
- Other than skin cancer less then 5 y prior to inclusion in study
- Chronic kidney disease
- Type I diabetes
- Hemoglobin < 5.0 mmol/l
- Participating in other studies
- Not suitable for inclusion
Sites / Locations
- Hvidovre Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo
Vitamin D administered orally
Vitamin D administered via UVB
Arm Description
Outcomes
Primary Outcome Measures
25-hydroxyvitamin D
Secondary Outcome Measures
T-lymphocytes subsets.
Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.
Ionized calcium
Parathyroid hormone
To evaluate bone-metabolism.
QoL score
Evaluation of self-reported health using two questionnaires:
QLQ-C30 QLQ-Pan(30)
Full Information
NCT ID
NCT01141998
First Posted
June 10, 2010
Last Updated
December 22, 2011
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01141998
Brief Title
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
Official Title
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose:
The overall objective of this study is to learn more about the disease chronic pancreatitis and thus contribute to better treatments. The investigators will gain this by studying the effects of vitamin D in the body immune system and bones. The investigators will also study the uptake of vitamin D through the intestine compared with the amount of vitamin D obtained through exposure to UVB rays.
The investigators have set a series of questions which the investigators want to answer with this experiment:
Do patients with chronic pancreatitis have reduced absorption of vitamin D from the gut?
Have the two treatment methods with vitamin D, UV radiation and tablets, the same success rate?
Does the distribution of the white blood cells change when the vitamin D level increases and does it depend on whether the patient have UVB radiation or tablet with vitamin D?
Will patients require reduced amounts of painkillers when vitamin D level increases?
Does vitamin D have influence on blood sugar and thus the risk of diabetes or worsening of this?
Could vitamin D affect the blood content of inflammation markers?
Does the patient feel better when he takes vitamin D?
Does bone strength increase when the patients receive grants of vitamin D?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Malabsorption Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Vitamin D administered orally
Arm Type
Active Comparator
Arm Title
Vitamin D administered via UVB
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Calcium, Dietary
Other Intervention Name(s)
Unikalk Basic
Intervention Description
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Unikalk Forte
Intervention Description
38 micrograms daily. Week 0-10.
Intervention Type
Radiation
Intervention Name(s)
UVB
Other Intervention Name(s)
Ergoline Flair 200
Intervention Description
Ultraviolet radiation type B administered in a tanning bed. One time weekly.
Intervention Type
Radiation
Intervention Name(s)
UV-filtered light.
Other Intervention Name(s)
Ergoline Flair 200
Intervention Description
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Unikalk Forte
Intervention Description
38 micrograms daily. From week 14 to 52.
Primary Outcome Measure Information:
Title
25-hydroxyvitamin D
Time Frame
Week 0, 2, 6, 10, 14, 20, 30, 40, 52
Secondary Outcome Measure Information:
Title
T-lymphocytes subsets.
Description
Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.
Time Frame
Week 0, 10
Title
Ionized calcium
Time Frame
week 0, 2, 6, 10, 14, 20, 30, 40, 52
Title
Parathyroid hormone
Description
To evaluate bone-metabolism.
Time Frame
Week 0, 2, 6, 10, 14, 20, 30, 40, 52
Title
QoL score
Description
Evaluation of self-reported health using two questionnaires:
QLQ-C30 QLQ-Pan(30)
Time Frame
Week 0, 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic pancreatitis
Malabsorption
Age min. 18 y.
25-hydroxyvitamin D less than 75 nmol/l
Body mass index < 30
Consent
Exclusion Criteria:
Acute pancreatitis
Cirrhosis
Ionized calcium > 1.35 mmol/l
Heart disease
Former resection of gastro-intestinal tract.
Pregnancy
Pancreatic malignant disease
History of skin cancer
Other than skin cancer less then 5 y prior to inclusion in study
Chronic kidney disease
Type I diabetes
Hemoglobin < 5.0 mmol/l
Participating in other studies
Not suitable for inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens-Erik B Jensen, Ph.d.
Organizational Affiliation
Dept. of osteoporosis, Hvidovre Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
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Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
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