Chronic Pancreatitis Clinical Trial
Official title:
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
Verified date | December 2011 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
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?
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
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 |
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