Back to resultsInfluence of Vitamin D on Inflammatory Bowel Disease Remission
Primary Purpose
Inflammatory Bowel Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vitamin D
Water or milk
Vitamin D enriched milk
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate inflammatory bowel disease
Exclusion Criteria:
- Hypersensitivity to milk products
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Vitamin D
Placebo
Unique vehicle for Vitamin D supplementation
Arm Description
Outcomes
Primary Outcome Measures
Inflammatory disease remission
Secondary Outcome Measures
Full Information
NCT ID
NCT01121796
First Posted
May 10, 2010
Last Updated
May 10, 2010
Sponsor
Hillel Yaffe Medical Center
Collaborators
Technion, Israel Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01121796
Brief Title
Influence of Vitamin D on Inflammatory Bowel Disease Remission
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
Collaborators
Technion, Israel Institute of Technology
4. Oversight
5. Study Description
Brief Summary
Vitamin D has been shown to influence a multitude of systems. We intend to see whether different types of Vitamin D supplements have an effect on inflammatory bowel disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Unique vehicle for Vitamin D supplementation
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Type
Other
Intervention Name(s)
Water or milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D enriched milk
Primary Outcome Measure Information:
Title
Inflammatory disease remission
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate inflammatory bowel disease
Exclusion Criteria:
Hypersensitivity to milk products
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zvi Fireman, MD
Email
fireman@hy.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Oren Atia, MD
Email
orena@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
12. IPD Sharing Statement
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Influence of Vitamin D on Inflammatory Bowel Disease Remission
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