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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

Tracking Information
First Submitted Date  ICMJE June 10, 2010
First Posted Date  ICMJE June 11, 2010
Last Update Posted Date December 23, 2011
Study Start Date  ICMJE December 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
25-hydroxyvitamin D [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01141998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
  • T-lymphocytes subsets. [ Time Frame: Week 0, 10 ]
    Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.
  • Ionized calcium [ Time Frame: week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]
  • Parathyroid hormone [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]
    To evaluate bone-metabolism.
  • QoL score [ Time Frame: Week 0, 10 ]
    Evaluation of self-reported health using two questionnaires: QLQ-C30 QLQ-Pan(30)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
Official Title  ICMJE Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
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?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pancreatitis
  • Malabsorption Syndromes
Intervention  ICMJE
  • 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: UVB
    Ultraviolet radiation type B administered in a tanning bed. One time weekly.
    Other Name: Ergoline Flair 200
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Calcium, Dietary
    • Radiation: UV-filtered light.
    • Drug: Cholecalciferol
  • Active Comparator: Vitamin D administered orally
    Interventions:
    • Drug: Calcium, Dietary
    • Drug: Cholecalciferol
    • Radiation: UV-filtered light.
    • Drug: Cholecalciferol
  • Experimental: Vitamin D administered via UVB
    Interventions:
    • Drug: Calcium, Dietary
    • Radiation: UVB
    • Drug: Cholecalciferol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2010)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01141998
Other Study ID Numbers  ICMJE Bang-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ulrich Bang, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jens-Erik B Jensen, Ph.d. Dept. of osteoporosis, Hvidovre Hospital
PRS Account Hvidovre University Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP