Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01792388
Other study ID # vip
Secondary ID
Status Completed
Phase Phase 4
First received December 19, 2012
Last updated July 21, 2014
Start date December 2011
Est. completion date March 2012

Study information

Verified date July 2014
Source University of Dublin, Trinity College
Contact n/a
Is FDA regulated No
Health authority Ireland: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin D
Capsule Form
Soya Bean oil
Capsule form

Locations

Country Name City State
Ireland Adelaide and Meath Hospital Dublin
Ireland Tallaght Hospital Dublin 24

Sponsors (3)

Lead Sponsor Collaborator
University of Dublin, Trinity College Queen Mary University of London, University of Calgary

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Intestinal Permability from baseline and 3 months Lactulose, Mannitol, Sucralose Test 0 and 3 months No
Secondary Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months Baseline and 3months No
Secondary To assess change in grip strength and associated fatigue markers Baseline and 3 months No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03815851 - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery N/A
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3