Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Study Overview
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Brief Summary
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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?

Official Title
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Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Conditions
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Chronic Pancreatitis, Malabsorption Syndromes

Intervention / Treatment
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* Drug: Calcium, Dietary
* Drug: Cholecalciferol
* Radiation: UVB
* Radiation: UV-filtered light.
* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Calcium, Dietary<br>* 400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.<br>* Other names: Unikalk Basic;Radiation: UV-filtered light.<br>* Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.<br>* Other names: Ergoline Flair 200;Drug: Cholecalciferol<br>* 38 micrograms daily. From week 14 to 52.<br>* Other names: Unikalk Forte;|
| Active Comparator: Vitamin D administered orally<br> | Drug: Calcium, Dietary<br>* 400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.<br>* Other names: Unikalk Basic;Drug: Cholecalciferol<br>* 38 micrograms daily. Week 0-10.<br>* Other names: Unikalk Forte;Radiation: UV-filtered light.<br>* Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.<br>* Other names: Ergoline Flair 200;Drug: Cholecalciferol<br>* 38 micrograms daily. From week 14 to 52.<br>* Other names: Unikalk Forte;|
| Experimental: Vitamin D administered via UVB<br> | Drug: Calcium, Dietary<br>* 400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.<br>* Other names: Unikalk Basic;Radiation: UVB<br>* Ultraviolet radiation type B administered in a tanning bed. One time weekly.<br>* Other names: Ergoline Flair 200;Drug: Cholecalciferol<br>* 38 micrograms daily. From week 14 to 52.<br>* Other names: Unikalk Forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-hydroxyvitamin D |  | Week 0, 2, 6, 10, 14, 20, 30, 40, 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-lymphocytes subsets. | Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes. | Week 0, 10 | 
| Ionized calcium |  | week 0, 2, 6, 10, 14, 20, 30, 40, 52 | 
| Parathyroid hormone | To evaluate bone-metabolism. | Week 0, 2, 6, 10, 14, 20, 30, 40, 52 | 
| QoL score | Evaluation of self-reported health using two questionnaires: QLQ-C30 QLQ-Pan(30) | Week 0, 10 |