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

University of Dublin, Trinity College

Status and phase: Completed; Phase 4

Conditions: Crohn's Disease

Treatments: Other: Placebo; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01369667

VITD/CD/01

Details and patient eligibility

About

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

Enrollment: 117 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

vitamin D

Active Comparator group

Description:

Capsule, one taken daily

Treatment:

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

Capsule, one taken daily

Treatment:

Other: Placebo