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Vitd and Barrier Function in IBD (VIP)

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ClinicalTrials.gov Identifier: NCT01792388
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : July 22, 2014
Sponsor:
Collaborators:
University of Calgary
Queen Mary University of London
Information provided by (Responsible Party):
Tara Raftery, University of Dublin, Trinity College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: Vitamin D Dietary Supplement: Soya Bean oil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission
Study Start Date : December 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Soya Bean oil Dietary Supplement: Soya Bean oil
Capsule form

Active Comparator: Vitamin D Dietary Supplement: Vitamin D
Capsule Form




Primary Outcome Measures :
  1. Change from Baseline Intestinal Permability from baseline and 3 months [ Time Frame: 0 and 3 months ]
    Lactulose, Mannitol, Sucralose Test


Secondary Outcome Measures :
  1. Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months [ Time Frame: Baseline and 3months ]
  2. To assess change in grip strength and associated fatigue markers [ Time Frame: Baseline and 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792388


Locations
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Ireland
Tallaght Hospital
Dublin 24, Ireland
Adelaide and Meath Hospital
Dublin, Ireland
Sponsors and Collaborators
University of Dublin, Trinity College
University of Calgary
Queen Mary University of London
Investigators
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Principal Investigator: Maria O'Sullivan, PhD Trinity College Dublin

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tara Raftery, Dr. Maria O'Sullivan, PhD, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT01792388     History of Changes
Other Study ID Numbers: vip
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by Tara Raftery, University of Dublin, Trinity College:
Crohn's Disease
Vitamin D
Intestinal Permeability
Tara Raftery

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents