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Completed

NCT Number: NCT01141998

Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

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?

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium, Dietary

Drug

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

Other names: Unikalk Basic

Cholecalciferol

Drug

38 micrograms daily. Week 0-10.

Other names: Unikalk Forte

UVB

Radiation

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

Other names: Ergoline Flair 200

UV-filtered light.

Radiation

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

Other names: Ergoline Flair 200

Primary outcomes

  1. 25-hydroxyvitamin D

    Time frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52

Secondary outcomes

  1. T-lymphocytes subsets.

    Time frame: Week 0, 10

    Subsets of T-lymphocytes including regulatory T-lymphocytes (Tregs) and CD4+ and CD8+ lymphocytes.

  2. Ionized calcium

    Time frame: week 0, 2, 6, 10, 14, 20, 30, 40, 52

  3. Parathyroid hormone

    Time frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52

    To evaluate bone-metabolism.

  4. QoL score

    Time frame: Week 0, 10

    Evaluation of self-reported health using two questionnaires:

    QLQ-C30 QLQ-Pan(30)

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 11, 2010
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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