Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Chronic Pancreatitis Clinical Trial

Official title:

Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141998
• Other study ID #: Bang-01
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: December 22, 2011
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Malabsorption Syndromes
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
• Cholecalciferol
38 micrograms daily. Week 0-10.

Radiation:
• UVB
Ultraviolet radiation type B administered in a tanning bed. One time weekly.
• UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.

Drug:
• Cholecalciferol
38 micrograms daily. From week 14 to 52.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D		Week 0, 2, 6, 10, 14, 20, 30, 40, 52	No
Secondary	T-lymphocytes subsets.	Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.	Week 0, 10	No
Secondary	Ionized calcium		week 0, 2, 6, 10, 14, 20, 30, 40, 52	Yes
Secondary	Parathyroid hormone	To evaluate bone-metabolism.	Week 0, 2, 6, 10, 14, 20, 30, 40, 52	No
Secondary	QoL score	Evaluation of self-reported health using two questionnaires: QLQ-C30 QLQ-Pan(30)	Week 0, 10	No