Influence of Vitamin D on Inflammatory Bowel Disease Remission

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Hillel Yaffe Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Technion, Israel Institute of Technology

Information provided by:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01121796

First received: May 10, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

May 10, 2010

Last Updated Date

May 10, 2010

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Inflammatory disease remission [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Influence of Vitamin D on Inflammatory Bowel Disease Remission

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Inflammatory Bowel Disease

Intervention ^ICMJE

Dietary Supplement: Vitamin D
Other: Water or milk
Dietary Supplement: Vitamin D enriched milk

Study Arm (s)

Active Comparator: Vitamin D
Intervention: Dietary Supplement: Vitamin D
Placebo Comparator: Placebo
Intervention: Other: Water or milk
Active Comparator: Unique vehicle for Vitamin D supplementation
Intervention: Dietary Supplement: Vitamin D enriched milk

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Mild to moderate inflammatory bowel disease

Exclusion Criteria:

Hypersensitivity to milk products

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Zvi Fireman, MD		fireman@hy.health.gov.il
Contact: Oren Atia, MD		orena@hy.health.gov.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01121796

Other Study ID Numbers ^ICMJE

HY100510

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Zvi Fireman, Director Gastroenterology Institute, Hillel Yaffe Medical Center

Study Sponsor ^ICMJE

Hillel Yaffe Medical Center

Collaborators ^ICMJE

Technion, Israel Institute of Technology

Investigators ^ICMJE

Not Provided

Information Provided By

Hillel Yaffe Medical Center

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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