Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
History of Changes
  Purpose

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 Intervention
Chronic Pancreatitis
Malabsorption Syndromes
 Drug: Calcium, Dietary
Drug: Cholecalciferol
Radiation: UVB
Radiation: UV-filtered light.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 25-hydroxyvitamin D [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Enrollment: 27
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141998

Locations
Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Jens-Erik B Jensen, Ph.d. Dept. of osteoporosis, Hvidovre Hospital
  More Information

Responsible Party: Ulrich Bang, M.D., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01141998     History of Changes
Other Study ID Numbers: Bang-01 
Study First Received: June 10, 2010
Last Updated: December 22, 2011
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Malabsorption Syndromes
Pancreatic Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Metabolic Diseases
Vitamins
 Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 27, 2016