Influence of Vitamin D on Inflammatory Bowel Disease Remi... | NCT01121796

Studies
Influence of Vitamin D on Inflammatory Bowel Disease Remission

NCT01121796

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

May 12, 2010Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Inflammatory Bowel Disease

Interventions

Vitamin D
Water or milk
Vitamin D enriched milk

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2011Estimated

Completion Date

Not provided

First Submitted Date

May 10, 2010

First Submission Date that Met QC Criteria

May 10, 2010

First Posted Date

May 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2010

Last Update Posted Date

May 12, 2010Estimated

Name	Class
Technion, Israel Institute of Technology	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Dietary Supplement		Vitamin D
Water or milk

Measure	Description	Time Frame
Inflammatory disease remission		One year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate inflammatory bowel disease

Exclusion Criteria:

Hypersensitivity to milk products

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zvi Fireman, MD	Contact			fireman@hy.health.gov.il
Oren Atia, MD	Contact			orena@hy.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D
D014867	Water
D008892	Milk

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided