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Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01141998
First received: June 10, 2010
Last updated: December 22, 2011
Last verified: December 2011

June 10, 2010
December 22, 2011
December 2009
May 2010   (final data collection date for primary outcome measure)
25-hydroxyvitamin D [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141998 on ClinicalTrials.gov Archive Site
  • T-lymphocytes subsets. [ Time Frame: Week 0, 10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Parathyroid hormone [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ] [ Designated as safety issue: No ]
    To evaluate bone-metabolism.
  • QoL score [ Time Frame: Week 0, 10 ] [ Designated as safety issue: No ]

    Evaluation of self-reported health using two questionnaires:

    QLQ-C30 QLQ-Pan(30)

Same as current
Not Provided
Not Provided
 
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

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?
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Chronic Pancreatitis
  • Malabsorption Syndromes
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
March 2011
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01141998
Bang-01
No
Ulrich Bang, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Study Director: Jens-Erik B Jensen, Ph.d. Dept. of osteoporosis, Hvidovre Hospital
Hvidovre University Hospital
December 2011

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