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?

Study Overview

• Status: Completed
• Conditions: Malabsorption Syndromes; Chronic Pancreatitis
• Intervention / Treatment: Drug: Calcium, Dietary; Drug: Cholecalciferol; Radiation: UV-filtered light.; Drug: Cholecalciferol; Radiation: UVB

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Unikalk Basic; Drug: Cholecalciferol; 38 micrograms daily. Week 0-10.; Other Names: Unikalk Forte; Radiation: UV-filtered light.; Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.; Other Names: Ergoline Flair 200; Drug: Cholecalciferol; 38 micrograms daily. From week 14 to 52.; Other Names: 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 Names: Unikalk Basic; Drug: Cholecalciferol; 38 micrograms daily. Week 0-10.; Other Names: Unikalk Forte; Radiation: UV-filtered light.; Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.; Other Names: Ergoline Flair 200; Drug: Cholecalciferol; 38 micrograms daily. From week 14 to 52.; Other Names: 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 Names: Unikalk Basic; Drug: Cholecalciferol; 38 micrograms daily. Week 0-10.; Other Names: Unikalk Forte; Drug: Cholecalciferol; 38 micrograms daily. From week 14 to 52.; Other Names: Unikalk Forte; Radiation: UVB; Ultraviolet radiation type B administered in a tanning bed. One time weekly.; Other Names: Ergoline Flair 200

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
25-hydroxyvitamin D	Week 0, 2, 6, 10, 14, 20, 30, 40, 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T-lymphocytes subsets.	Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.	Week 0, 10
Ionized calcium		week 0, 2, 6, 10, 14, 20, 30, 40, 52
Parathyroid hormone	To evaluate bone-metabolism.	Week 0, 2, 6, 10, 14, 20, 30, 40, 52
QoL score	Evaluation of self-reported health using two questionnaires: QLQ-C30 QLQ-Pan(30)	Week 0, 10

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Director: Jens-Erik B Jensen, Ph.d., Dept. of osteoporosis, Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: June 10, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (ESTIMATE): June 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 23, 2011
• Last Update Submitted That Met QC Criteria: December 22, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic; Malabsorption Syndromes; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcium; Calcium, Dietary
• Other Study ID Numbers: Bang-01