|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00742781 |
|
Date of registration:
|
26/08/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Vitamin D Supplementation in Crohn's Patients
CTSA |
|
Scientific title:
|
Vitamin D and Crohn's Disease" From the Bench to the Clinic |
|
Date of first enrolment:
|
May 2009 |
|
Target sample size:
|
21 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00742781 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Margherita T Cantorna, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Penn State University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients 18-70 years of age with mild to moderate Crohn's disease who are not on
active steroid treatment and who do not have ostomies.
Exclusion Criteria:
- Patients with ulcerative colitis or other bowel conditions which are not Crohn's.
- Patients with ostomies.
- Those currently using supplemental vitamin D in excess of the amount in one
multivitamin per day.
- Regular tanning bed users.
- Persons who report more than moderate alcohol consumption ( > 1 drink/day for women >
2 for men).
- Pregnant or lactating women or women planning a pregnancy during the study time frame.
- Regular users of medications which may interfere with assessment of study outcomes .
- Those who cannot understand written or spoken English .
- Individuals under medical psychiatric care.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Inflammatory Bowel Disease
|
|
Intervention(s)
|
|
Dietary Supplement: Vitamin D
|
|
Primary Outcome(s)
|
|
25(OH)D3 Serum Levels
[Time Frame: 6 months]
|
|
Crohn's Disease Activity Index
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Health Improvement
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
CTSA-PPA-1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|