Vitamin D Supplementation in Adult Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamin D

Capsule, one taken daily

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Capsule, one taken daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No