Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
This study has been completed.
Sponsor:
Hvidovre University Hospital
Information provided by (Responsible Party):
Ulrich Bang, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01141998
First received: June 10, 2010
Last updated: December 22, 2011
Last verified: December 2011
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Chronic Pancreatitis Malabsorption Syndromes |
Drug: Calcium, Dietary Drug: Cholecalciferol Radiation: UVB Radiation: UV-filtered light. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption |
Resource links provided by NLM:
Further study details as provided by Hvidovre University Hospital:
Primary Outcome Measures:
- 25-hydroxyvitamin D [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- T-lymphocytes subsets. [ Time Frame: Week 0, 10 ] [ Designated as safety issue: No ]Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.
- Ionized calcium [ Time Frame: week 0, 2, 6, 10, 14, 20, 30, 40, 52 ] [ Designated as safety issue: Yes ]
- Parathyroid hormone [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ] [ Designated as safety issue: No ]To evaluate bone-metabolism.
- QoL score [ Time Frame: Week 0, 10 ] [ Designated as safety issue: No ]
Evaluation of self-reported health using two questionnaires:
QLQ-C30 QLQ-Pan(30)
| Enrollment: | 27 |
| Study Start Date: | December 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Calcium, Dietary
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
Other Name: Unikalk Basic
Radiation: UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Other Name: Ergoline Flair 200
Drug: Cholecalciferol
38 micrograms daily. From week 14 to 52.
Other Name: 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 Name: Unikalk Basic
Drug: Cholecalciferol
38 micrograms daily. Week 0-10.
Other Name: Unikalk Forte
Radiation: UV-filtered light.
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
Other Name: Ergoline Flair 200
Drug: Cholecalciferol
38 micrograms daily. From week 14 to 52.
Other Name: 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 Name: Unikalk Basic
Radiation: UVB
Ultraviolet radiation type B administered in a tanning bed. One time weekly.
Other Name: Ergoline Flair 200
Drug: Cholecalciferol
38 micrograms daily. From week 14 to 52.
Other Name: Unikalk Forte
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141998
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141998
Locations
| Denmark | |
| Hvidovre Hospital | |
| Hvidovre, Denmark, 2650 | |
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
| Study Director: | Jens-Erik B Jensen, Ph.d. | Dept. of osteoporosis, Hvidovre Hospital |
More Information
No publications provided
| Responsible Party: | Ulrich Bang, M.D., Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT01141998 History of Changes |
| Other Study ID Numbers: | Bang-01 |
| Study First Received: | June 10, 2010 |
| Last Updated: | December 22, 2011 |
| Health Authority: | Denmark: Ethics Committee |
Additional relevant MeSH terms:
|
Malabsorption Syndromes Pancreatitis Pancreatitis, Chronic Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Metabolic Diseases Pancreatic Diseases |
Cholecalciferol Vitamin D Vitamins Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015