Chronic PancreatitisNCT01141998
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
A study testing Calcium, Dietary, Cholecalciferol and UVB in people with Chronic Pancreatitis and Malabsorption Syndromes, run by Hvidovre University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Malabsorption Syndromes
- What is being tested?
- Calcium, Dietary, Cholecalciferol and UVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pancreatitis
- Malabsorption
- Age min. 18 y.
- 25-hydroxyvitamin D less than 75 nmol/l
- Body mass index < 30
- Consent
Who cannot join
- Acute pancreatitis
- Cirrhosis
- Ionized calcium > 1.35 mmol/l
- Heart disease
- Former resection of gastro-intestinal tract.
- Pregnancy
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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?
- Conditions
- Chronic Pancreatitis, Malabsorption Syndromes
- Being tested
- Calcium, Dietary, Cholecalciferol, UVB, UV-filtered light.
- Medical subject headings
- Pancreatitis, Chronic, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium, DietaryDrug
Also called Unikalk Basic
400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
CholecalciferolDrug
Also called Unikalk Forte
38 micrograms daily. Week 0-10.
UVBRadiation
Also called Ergoline Flair 200
Ultraviolet radiation type B administered in a tanning bed. One time weekly.
UV-filtered light.Radiation
Also called Ergoline Flair 200
Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
CholecalciferolDrug
Also called Unikalk Forte
38 micrograms daily. From week 14 to 52.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Calcium, Dietary; Radiation: UV-filtered light.; Drug: Cholecalciferol |
| Vitamin D administered orally | Active comparator | Not described Receives: Drug: Calcium, Dietary; Drug: Cholecalciferol; Radiation: UV-filtered light. |
| Vitamin D administered via UVB | Experimental | Not described Receives: Drug: Calcium, Dietary; Radiation: UVB; Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxyvitamin D
Measured: Week 0, 2, 6, 10, 14, 20, 30, 40, 52
Secondary outcomes (4)
T-lymphocytes subsets.
Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.
Measured: Week 0, 10
Ionized calcium
Measured: week 0, 2, 6, 10, 14, 20, 30, 40, 52
Parathyroid hormone
To evaluate bone-metabolism.
Measured: Week 0, 2, 6, 10, 14, 20, 30, 40, 52
QoL score
Evaluation of self-reported health using two questionnaires:
QLQ-C30 QLQ-Pan(30)
Measured: Week 0, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Bang, Hvidovre University Hospital
- Investigators
- Jens-Erik B Jensen, Ph.d., Study director, Dept. of osteoporosis, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141998
- Sponsor's protocol ID
- Bang-01
- Status last verified
- Dec 2011
- First submitted
- 10 Jun 2010
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption
- ClinicalTrials.gov ID
- NCT01141998
- Acronym / sponsor ID
- Bang-01
- Conditions
- Chronic Pancreatitis, Malabsorption Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Calcium, Dietary, Radiation: UV-filtered light., Drug: Cholecalciferol |
| Vitamin D administered orally | Active comparator | Drug: Calcium, Dietary, Drug: Cholecalciferol, Radiation: UV-filtered light. |
| Vitamin D administered via UVB | Experimental | Drug: Calcium, Dietary, Radiation: UVB, Drug: Cholecalciferol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic pancreatitis
- Malabsorption
- Age min. 18 y.
- 25-hydroxyvitamin D less than 75 nmol/l
- Body mass index < 30
Key exclusion criteria (14 listed)
- Acute pancreatitis
- Cirrhosis
- Ionized calcium > 1.35 mmol/l
- Heart disease
- Former resection of gastro-intestinal tract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium, DietaryAlso: Unikalk Basic400 mg calcium two times daily. From week 0 to 10 and week 14 to 52. | Drug | Placebo, Vitamin D administered orally, Vitamin D administered via UVB |
| CholecalciferolAlso: Unikalk Forte38 micrograms daily. Week 0-10. | Drug | Vitamin D administered orally |
| UVBAlso: Ergoline Flair 200Ultraviolet radiation type B administered in a tanning bed. One time weekly. | Radiation | Vitamin D administered via UVB |
| UV-filtered light.Also: Ergoline Flair 200Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly. | Radiation | Placebo, Vitamin D administered orally |
| CholecalciferolAlso: Unikalk Forte38 micrograms daily. From week 14 to 52. | Drug | Placebo, Vitamin D administered orally, Vitamin D administered via UVB |
Primary outcome
25-hydroxyvitamin D
Time frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52
4 secondary outcomes
T-lymphocytes subsets.
Time frame: Week 0, 10
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
QoL score
Time frame: Week 0, 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens-Erik B Jensen, Ph.d. study director
Dept. of osteoporosis, Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium, Dietary, Cholecalciferol and UVB in people with Chronic Pancreatitis and Malabsorption Syndromes, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25-hydroxyvitamin D (time frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2011.