Vitd and Barrier Function in IBD (VIP)

University of Dublin, Trinity College

Status and phase

Completed

Phase 4

Conditions

Crohn's Disease

Treatments

Dietary Supplement: Vitamin D

Dietary Supplement: Soya Bean oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01792388

vip

Details and patient eligibility

About

Increased Intestinal Permeability is detectable in clinically active Crohn's disease, in stable Crohn's disease and is predictive of clinical relapse. Maintenance of the epithelial barrier integrity is therefore essential for intestinal homeostasis. Vitamin D may have a critical role in improving barrier function.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients must fulfill the clinical criteria for diagnosis of CD as defined by Lennard-Jones et al. (1976)
All patients must be in clinical remission for at least 1 month at study entry as defined by a Crohn's Disease Activity Index (CDAI) of <150
18-65 years
Patients on stable drug therapies for at least 1 month pre-enrolment
Sufficient English language ability to carry out the study requirements

Exclusion criteria

Symptomatic CD at study entry including CDAI >150
Pregnancy
Previous extensive small bowel resection (less than 200 cm of viable small bowel or a loss of 50% or more of the small intestine)
Presence of an ileostomy or colostomy
Known hypersensitivity to vitamin D
Hypercalcaemia (corrected serum calcium > 2.66 mmol/L)
Those currently using supplemental vitamin D >800 IU/D
Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, renal failure, pseudohyperparathyroidism, malignancy, active, lymphoma, short bowel syndrome
Antibiotic use in the 4 weeks prior to enrolment
Current use of bisphosphonates
Renal Impairment, Diabetes Mellitus
Patients participating in a concurrent RCT
Alcohol dependency