NCT01121796

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

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

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

May 12, 2010

Status Verified

May 1, 2010

Enrollment Period

1 year

First QC Date

May 10, 2010

Last Update Submit

May 10, 2010

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Inflammatory disease remission

    One year

Study Arms (3)

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

Vitamin DDIETARY_SUPPLEMENT
Vitamin D
Water or milkOTHER
Placebo
Vitamin D enriched milkDIETARY_SUPPLEMENT
Unique vehicle for Vitamin D supplementation

Eligibility Criteria

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

You may qualify if:

  • Mild to moderate inflammatory bowel disease

You may not qualify if:

  • Hypersensitivity to milk products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Vitamin DWaterMilk

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Central Study Contacts

Zvi Fireman, MD

CONTACT

fireman@hy.health.gov.il

Oren Atia, MD

CONTACT

orena@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Last Updated

May 12, 2010

Record last verified: 2010-05

Locations

IL(1)