Vitamin D Supplementation in Adult Crohn's Disease

Phase 4

Completed

• Conditions: Crohn's Disease
• Interventions: Dietary Supplement: Vitamin D3; Other: Placebo

• Registration Number: NCT01369667
• Lead Sponsor: University of Dublin, Trinity College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-06
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-09
• Study Start: 2012-04
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Last Update Submitted: 2015-08-15
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitamin D	Vitamin D3	Capsule, one taken daily
Placebo	Placebo	Capsule, one taken daily

Primary Outcome Measures

Name	Time	Method
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.	12 Months

Trial Locations

Locations (1)

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,; 🇮🇪 Dublin 24, Ireland