Clinical Trial: Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

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?

Detailed Summary:
Sponsor: Hvidovre University Hospital

Current Primary Outcome: 25-hydroxyvitamin D [ Time Frame: Week 0, 2, 6, 10, 14, 20, 30, 40, 52 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)



Original Secondary Outcome: Same as current

Information By: Hvidovre University Hospital

Dates:
Date Received: June 10, 2010
Date Started: December 2009
Date Completion:
Last Updated: December 22, 2011
Last Verified: December 2011