Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
NCT ID: NCT01141998
Last Updated: 2011-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2009-12-31
2011-03-31
Brief Summary
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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?
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Cholecalciferol
38 micrograms daily. From week 14 to 52.
Vitamin D administered orally
Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
Cholecalciferol
38 micrograms daily. Week 0-10.
UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Cholecalciferol
38 micrograms daily. From week 14 to 52.
Vitamin D administered via UVB
Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
UVB
Ultraviolet radiation type B administered in a tanning bed. One time weekly.
Cholecalciferol
38 micrograms daily. From week 14 to 52.
Interventions
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Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
Cholecalciferol
38 micrograms daily. Week 0-10.
UVB
Ultraviolet radiation type B administered in a tanning bed. One time weekly.
UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Cholecalciferol
38 micrograms daily. From week 14 to 52.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Malabsorption
* Age min. 18 y.
* 25-hydroxyvitamin D less than 75 nmol/l
* Body mass index \< 30
* Consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Ulrich Bang
M.D.
Principal Investigators
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Jens-Erik B Jensen, Ph.d.
Role: STUDY_DIRECTOR
Dept. of osteoporosis, Hvidovre Hospital
Locations
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Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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Bang-01
Identifier Type: -
Identifier Source: org_study_id