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Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

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ClinicalTrials.gov Identifier: NCT01141998
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital

Study Description
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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?

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Malabsorption Syndromes Drug: Calcium, Dietary Drug: Cholecalciferol Radiation: UVB Radiation: UV-filtered light. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
Study Start Date : December 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
Other Name: Unikalk Basic

Radiation: UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Other Name: Ergoline Flair 200

Drug: Cholecalciferol
38 micrograms daily. From week 14 to 52.
Other Name: Unikalk Forte
Active Comparator: Vitamin D administered orally Drug: Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
Other Name: Unikalk Basic

Drug: Cholecalciferol
38 micrograms daily. Week 0-10.
Other Name: Unikalk Forte

Radiation: UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Other Name: Ergoline Flair 200

Drug: Cholecalciferol
38 micrograms daily. From week 14 to 52.
Other Name: Unikalk Forte
Experimental: Vitamin D administered via UVB Drug: Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
Other Name: Unikalk Basic

Radiation: UVB
Ultraviolet radiation type B administered in a tanning bed. One time weekly.
Other Name: Ergoline Flair 200

Drug: Cholecalciferol
38 micrograms daily. From week 14 to 52.
Other Name: Unikalk Forte


Outcome Measures
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Primary Outcome Measures :
  1. 25-hydroxyvitamin D [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]

Secondary Outcome Measures :
  1. T-lymphocytes subsets. [ Time Frame: Week 0, 10 ]
    Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.

  2. Ionized calcium [ Time Frame: week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]
  3. Parathyroid hormone [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]
    To evaluate bone-metabolism.

  4. QoL score [ Time Frame: Week 0, 10 ]

    Evaluation of self-reported health using two questionnaires:

    QLQ-C30 QLQ-Pan(30)



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141998


Locations
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Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Study Director: Jens-Erik B Jensen, Ph.d. Dept. of osteoporosis, Hvidovre Hospital
More Information
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Responsible Party: Ulrich Bang, M.D., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01141998     History of Changes
Other Study ID Numbers: Bang-01
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Malabsorption Syndromes
Pancreatic Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Metabolic Diseases
Vitamin D
Ergocalciferols
 Calcium, Dietary
Cholecalciferol
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents