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Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01141998
Enrollment
27
Registered
2010-06-11
Start date
2009-12-31
Completion date
2011-03-31
Last updated
2011-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis, Malabsorption Syndromes

Brief 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. 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?

Interventions

DRUGCalcium, Dietary

400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.

DRUGCholecalciferol

38 micrograms daily. Week 0-10.

RADIATIONUVB

Ultraviolet radiation type B administered in a tanning bed. One time weekly.

RADIATIONUV-filtered light.

Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
25-hydroxyvitamin DWeek 0, 2, 6, 10, 14, 20, 30, 40, 52

Secondary

MeasureTime frameDescription
T-lymphocytes subsets.Week 0, 10Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.
Ionized calciumweek 0, 2, 6, 10, 14, 20, 30, 40, 52
Parathyroid hormoneWeek 0, 2, 6, 10, 14, 20, 30, 40, 52To evaluate bone-metabolism.
QoL scoreWeek 0, 10Evaluation of self-reported health using two questionnaires: QLQ-C30 QLQ-Pan(30)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026