Trial record 5 of 585 for:    "Crohns disease"

Vitamin D Treatment for Crohn´s Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00132184
First received: August 18, 2005
Last updated: April 12, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Crohns Disease
Drug: Vitamin D
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

Estimated Enrollment: 110
Study Start Date: September 2005
Estimated Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00132184     History of Changes
Other Study ID Numbers: 2005-001216-50
Study First Received: August 18, 2005
Last Updated: April 12, 2007
Health Authority: Denmark: Danish Medicines Agency

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
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 21, 2014