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Vitamin D Supplementation in Adult Crohn's Disease (VITD-CD)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
University of Dublin, Trinity College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients must fulfill the clinical criteria for diagnosis of Crohn's disease.
  • Subjects must have inactive CD as defined by CDAI < 150
  • CRP </=10 mg/L.

Exclusion Criteria:

  • Pregnant and lactating women.
  • Known hypersensitivity to vitamin D.
  • Hypercalcaemia
  • Current supplemental intake of vitamin D3 >800 IU/D.
  • Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma.
  • Participation in a concurrent clinical trial.

Sites / Locations

  • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin D

Placebo

Arm Description

Capsule, one taken daily

Capsule, one taken daily

Outcomes

Primary Outcome Measures

Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2011
Last Updated
August 15, 2015
Sponsor
University of Dublin, Trinity College
Collaborators
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT01369667
Brief Title
Vitamin D Supplementation in Adult Crohn's Disease
Acronym
VITD-CD
Official Title
Vitamin D and Immunomodulation: Effects in Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dublin, Trinity College
Collaborators
Queen Mary University of London

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D
Arm Type
Active Comparator
Arm Description
Capsule, one taken daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsule, one taken daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must fulfill the clinical criteria for diagnosis of Crohn's disease. Subjects must have inactive CD as defined by CDAI < 150 CRP </=10 mg/L. Exclusion Criteria: Pregnant and lactating women. Known hypersensitivity to vitamin D. Hypercalcaemia Current supplemental intake of vitamin D3 >800 IU/D. Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma. Participation in a concurrent clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria O'Sullivan, PhD
Organizational Affiliation
TCD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,
City
Dublin 24
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30649836
Citation
O'Sullivan F, Raftery T, van Weele M, van Geffen J, McNamara D, O'Morain C, Mahmud N, Kelly D, Healy M, O'Sullivan M, Zgaga L. Sunshine is an Important Determinant of Vitamin D Status Even Among High-dose Supplement Users: Secondary Analysis of a Randomized Controlled Trial in Crohn's Disease Patients. Photochem Photobiol. 2019 Jul;95(4):1060-1067. doi: 10.1111/php.13086. Epub 2019 Mar 12.
Results Reference
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Vitamin D Supplementation in Adult Crohn's Disease

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