Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
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ClinicalTrials.gov Identifier: NCT01141998 |
Recruitment Status :
Completed
First Posted : June 11, 2010
Last Update Posted : December 23, 2011
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Pancreatitis Malabsorption Syndromes | Drug: Calcium, Dietary Drug: Cholecalciferol Radiation: UVB Radiation: UV-filtered light. | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
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 |
- 25-hydroxyvitamin D [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]
- T-lymphocytes subsets. [ Time Frame: Week 0, 10 ]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 ]
- Parathyroid hormone [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]To evaluate bone-metabolism.
- QoL score [ Time Frame: Week 0, 10 ]
Evaluation of self-reported health using two questionnaires:
QLQ-C30 QLQ-Pan(30)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141998
Denmark | |
Hvidovre Hospital | |
Hvidovre, Denmark, 2650 |
Study Director: | Jens-Erik B Jensen, Ph.d. | Dept. of osteoporosis, Hvidovre Hospital |
Responsible Party: | Ulrich Bang, M.D., Hvidovre University Hospital |
ClinicalTrials.gov Identifier: | NCT01141998 History of Changes |
Other Study ID Numbers: |
Bang-01 |
First Posted: | June 11, 2010 Key Record Dates |
Last Update Posted: | December 23, 2011 |
Last Verified: | December 2011 |
Pancreatitis Pancreatitis, Chronic Malabsorption Syndromes Pancreatic Diseases Digestive System Diseases Intestinal Diseases Gastrointestinal Diseases Metabolic Diseases Vitamin D Ergocalciferols |
Calcium, Dietary Cholecalciferol Vitamins Calcium Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |