Investigating the benefits of a targeted highly refined nutritional supplement to reduce inflammation in people with Inflammatory Bowel Disease (IBD) in New Zealand
Not Applicable
Completed
- Conditions
- Inflammatory Bowel Disease (IBD)Crohn's diseaseOral and Gastrointestinal - Inflammatory bowel diseaseOral and Gastrointestinal - Crohn's disease
- Registration Number
- ACTRN12615000855527
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
Have a diagnosis of Crohn's disease.
Exclusion Criteria
Have had a history of cancer in the last 5 years excluding non- melanoma skin cancers.
Have smoked (the equivalent of more than 10 pack years) or are smoking
Have changes in medicine in the last 3 months,
Have taken antibiotics in the last three months,
Are on blood thinners,
Are not willing to stop taking similar nutrient supplements 4 weeks before the trial begins,
Would eat 4 meals or more each week of oily fish through the trial
Would use a sunbed during the trial
Are not willing to give Doctors name and contact details
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inflammation biomarkers (e.g. CRP, as measured in blood plasma and faecal calprotectin as measured in the faeces) in a patient population which has IBD[After 6 weeks exposure]; Serum Vitamin D concentrations, as measured by isotope-dilution liquid chromatography-tandem mass spectrometry (LCMS) [6 weeks];Availability of omega-3 PUFA as measured by FAME analysis.[6 weeks]
- Secondary Outcome Measures
Name Time Method Signs and symptoms associated with IBD. These will be measured by the completion of two Quality of Life Measures (The short quality of Life Questionnaire with IBD, the Quality of Life Score using a numeric Rating Scale) and a faecal and symptom diary.[6 weeks]