NCT00132184

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 13, 2007

Status Verified

April 1, 2007

First QC Date

August 18, 2005

Last Update Submit

April 12, 2007

Conditions

Crohns Disease

Keywords

Vitamin DCrohns Disease

Outcome Measures

Primary Outcomes (1)

  • Relapse rate within 1 year treatment; CDAI>220

Interventions

Vitamin DDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hypercalcemia
  • Short bowel syndrome
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aarhus University Hospital, Department V

Aarhus, 8000, Denmark

Location

Hospital of Horsens

Horsens, 8700, Denmark

Location

Hospital of Randers

Randers, 8900, Denmark

Location

Hospital of Silkeborg

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jens F. Dahlerup, MD, DrMedSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

September 1, 2005

Study Completion

February 1, 2008

Last Updated

April 13, 2007

Record last verified: 2007-04

Locations

DK(4)