ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Treatment for Crohn´s Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00132184
Recruitment Status : Unknown
Verified April 2007 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2005
Last Update Posted : April 13, 2007
Sponsor:
Information provided by:
University of Aarhus

Brief Summary:
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohns Disease Drug: Vitamin D Phase 2 Phase 3

Detailed Description:

Crohns Disease is an inflammatory disease of primarily the small intestine and colon.

In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.


Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
Study Start Date : September 2005
Estimated Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources




Primary Outcome Measures :
  1. Relapse rate within 1 year treatment; CDAI>220


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Crohn's disease
  • Inactive Crohn's disease for at least 4 weeks
  • Crohn's Disease Activity Index (CDAI) < 150
  • C-reactive protein within normal range
  • Serum albumin within normal range

Exclusion Criteria:

  • Hypercalcemia
  • Short bowel syndrome
  • Pregnancy

Information from the National Library of Medicine

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): NCT00132184


Locations
Denmark
Aarhus University Hospital, Department V
Aarhus, Denmark, 8000
Hospital of Horsens
Horsens, Denmark, 8700
Hospital of Randers
Randers, Denmark, 8900
Hospital of Silkeborg
Silkeborg, Denmark, 8600
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens F. Dahlerup, MD, DrMedSc Aarhus University Hospital

ClinicalTrials.gov Identifier: NCT00132184     History of Changes
Other Study ID Numbers: 2005-001216-50
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: April 13, 2007
Last Verified: April 2007

Keywords provided by University of Aarhus:
Vitamin D
Crohns Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents