Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

NCT01141998 | Completed

• 1 other identifier: Bang-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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?

Conditions

Chronic Pancreatitis; Malabsorption Syndromes

Outcome Measures

Primary Outcomes (1)

• 25-hydroxyvitamin D

  Week 0, 2, 6, 10, 14, 20, 30, 40, 52

Secondary Outcomes (4)

• T-lymphocytes subsets.

  Week 0, 10

• Ionized calcium

  week 0, 2, 6, 10, 14, 20, 30, 40, 52

• Parathyroid hormone

  Week 0, 2, 6, 10, 14, 20, 30, 40, 52

• QoL score

  Week 0, 10

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Calcium, Dietary; Radiation: UV-filtered light.; Drug: Cholecalciferol

Vitamin D administered orally

ACTIVE COMPARATOR

Drug: Calcium, Dietary; Drug: Cholecalciferol; Radiation: UV-filtered light.

Vitamin D administered via UVB

EXPERIMENTAL

Drug: Calcium, Dietary; Radiation: UVB; Drug: Cholecalciferol

Interventions

Calcium, Dietary DRUG

400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.

Also known as: Unikalk Basic

Placebo; Vitamin D administered orally; Vitamin D administered via UVB

Cholecalciferol DRUG

38 micrograms daily. Week 0-10.

Also known as: Unikalk Forte

Vitamin D administered orally

UVB RADIATION

Ultraviolet radiation type B administered in a tanning bed. One time weekly.

Also known as: Ergoline Flair 200

Vitamin D administered via UVB

UV-filtered light. RADIATION

Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.

Also known as: Ergoline Flair 200

Placebo; Vitamin D administered orally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pancreatitis
• Malabsorption
• Age min. 18 y.
• hydroxyvitamin D less than 75 nmol/l
• Body mass index \< 30
• Consent

You may not qualify if:

• 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
• Chronic kidney disease
• Type I diabetes
• Hemoglobin \< 5.0 mmol/l
• Participating in other studies

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Malabsorption Syndromes

Interventions

Calcium, Dietary; Cholecalciferol

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jens-Erik B Jensen, Ph.d.

  Dept. of osteoporosis, Hvidovre Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: December 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: March 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

DK (1)