Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption - Full Text View

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Malabsorption Syndromes Pancreatitis Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by Ulrich Bang, Hvidovre University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)


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)
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

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

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 21, 2017