Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01141998
• Date of registration: 10/06/2010
• Prospective Registration: No
• Primary sponsor: Hvidovre University Hospital
• Public title: Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
• Scientific title: Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
• Date of first enrolment: December 2009
• Target sample size: 27
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01141998
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Jens-Erik B Jensen, Ph.d.
• Affiliation: Dept. of osteoporosis, Hvidovre Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Malabsorption Syndromes

Chronic Pancreatitis

Intervention(s)

Radiation: UV-filtered light.

Drug: Calcium, Dietary

Drug: Cholecalciferol

Radiation: UVB

Primary Outcome(s)

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

Secondary Outcome(s)

Parathyroid hormone [Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52]

T-lymphocytes subsets. [Time Frame: Week 0, 10]

QoL score [Time Frame: Week 0, 10]

Ionized calcium [Time Frame: week 0, 2, 6, 10, 14, 20, 30, 40, 52]

Secondary ID(s)

Bang-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors