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OpenTrials
Completed

NCT Number: NCT01792388

Vitd and Barrier Function in IBD

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Adelaide and Meath Hospital, Dublin, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Capsule Form

Soya bean oil

Dietary Supplement

Capsule form

Primary outcomes

  1. Change from Baseline Intestinal Permability from baseline and 3 months

    Time frame: 0 and 3 months

    Lactulose, Mannitol, Sucralose Test

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Collaborators

  • Queen Mary University of London
  • University of Calgary

Registry information

Official study title

Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission

Acronym: VIP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2013
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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