Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000855527
Ethics application status
Approved
Date submitted
29/07/2015
Date registered
17/08/2015
Date last updated
15/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the benefits of a targeted highly refined nutritional supplement to reduce inflammation in people with Inflammatory Bowel Disease (IBD) in New Zealand
Scientific title
Investigating whether a targeted nutrient supplement reduces inflammation in people with Inflammatory Bowel Disease
Secondary ID [1] 287174 0
Nil
Universal Trial Number (UTN)
U1111-1172-6331
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease (IBD) 295740 0
Crohn's disease 295741 0
Condition category
Condition code
Oral and Gastrointestinal 296018 296018 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 296128 296128 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the a nutritional, targeted refined supplement, to see if this product reduces inflammation, as well as signs and symptoms in adults with IBD. This supplement is made up of Omega – 3 fish oil, (more than 500mg); vitamin D:25-OH (500IU); CoQ10 (50mg); zeaxanthin (0.82mg); ,lutein (3mg) and astaxanthin (500mcg). It also contains natural mixed tocopherols, vitamin E with ascorbyl palmitate (1mg). It will be taken orally - 2 capsules a day with the main meal. Adherence is monitored by supplement capsule return. This trial will be conducted as a controlled, double blinded, randomized, cross-over intervention trial over 18 weeks. The duration of the nutritional supplement is 6 weeks, The washout period is 6 weeks.
Intervention code [1] 292445 0
Treatment: Other
Comparator / control treatment
The control treatment is an omega three fish oil which is the same as contained in the supplement.. The control will be taken for 6 weeks
Control group
Active

Outcomes
Primary outcome [1] 295684 0
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
Timepoint [1] 295684 0
After 6 weeks exposure
Primary outcome [2] 295685 0
Serum Vitamin D concentrations, as measured by isotope-dilution liquid chromatography-tandem mass spectrometry (LCMS)
Timepoint [2] 295685 0
6 weeks
Primary outcome [3] 295686 0
Availability of omega-3 PUFA as measured by FAME analysis.
Timepoint [3] 295686 0
6 weeks
Secondary outcome [1] 316225 0
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.
Timepoint [1] 316225 0
6 weeks

Eligibility
Key inclusion criteria
Have a diagnosis of Crohn's disease.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects will be selected from an already existing IBD data base from Nutrigenomics New Zealand. They will be invited to participate. They will initially complete an eligibility questionnaire and dietary questionnaire for prescreening. Once eligible, an information sheet and the consent form will be discussed and sent- to be returned, signed, by post/email/ handed to the study centre. Participants will then be given specific instructions on how the study will proceed. Once the consent forms are received, they will be registered in the study and given a study code number. After coding they will be randomised into the 2 arms of the study by an independent person so the study will be double blinded. One arm will receive the supplement first and the other arm will receive the control first.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomized into the 2 arms of the study by an independent person who will use a random sequence (excel generated) using the codes of the participants
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
General linear mixed model.
The number of participants for this trial was based on the Jorgensen’s et al. ‘Vitamin D3 treatment in Crohn’s disease–a randomized double-blind placebo-controlled study’. (Aliment Pharmacol Ther. 2010;32(3):377-83). Prior data indicates that the difference in the response of matched pairs is normally distributed with standard deviation 4. If the true difference in the mean response of matched pairs is 27 we will be able to reject the null hypothesis that this response difference is zero with probability (power) 1.000. The Type I error probability associated with this test of this null hypothesis is 0.05. (R: A language and environment for statistical computing. Vienna, Austria. Cary, NC, USA.2012).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2015
Actual
19/01/2016
Date of last participant enrolment
Anticipated
11/09/2015
Actual
3/03/2016
Date of last data collection
Anticipated
Actual
18/07/2016
Sample size
Target
27
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 7057 0
New Zealand
State/province [1] 7057 0
Auckland

Funding & Sponsors
Funding source category [1] 291736 0
Other Collaborative groups
Name [1] 291736 0
Nutrigenomics New Zealand
Country [1] 291736 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Discipline of Nutrition and Dietetics,
Faculty of Medical and Health Sciences,
University of Auckland,
85 Park Rd,
Grafton Campus, Auckland New Zealand 1142
Country
New Zealand
Secondary sponsor category [1] 290410 0
None
Name [1] 290410 0
Address [1] 290410 0
Country [1] 290410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293258 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 293258 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293258 0
New Zealand
Date submitted for ethics approval [1] 293258 0
07/08/2015
Approval date [1] 293258 0
19/11/2015
Ethics approval number [1] 293258 0

Summary
Brief summary
This study will investigate a nutritional, targeted refined supplement, to see if this product reduces inflammation in adults with IBD. We hypothesize that the targeted nutritional supplement is able to reduce inflammation in a patient population which has IBD, as well as increasing serum Vitamin D, increasing availability of omega-3 PUFA, and reducing symptoms associated with IBD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59138 0
Prof Lynnette R Ferguson
Address 59138 0
Discipline of Nutrition and Dietetics
Faculty of Medical and Health Sciences,
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 59138 0
New Zealand
Phone 59138 0
+64 9 9236372
Fax 59138 0
: +64 9 373 7502
Email 59138 0
l.ferguson@auckland.ac.nz
Contact person for public queries
Name 59139 0
Ms Bobbi Laing
Address 59139 0
Discipline of Nutrition and Dietetics
Faculty of Medical and Health Sciences,
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 59139 0
New Zealand
Phone 59139 0
+64 9 9237528
Fax 59139 0
: +64 9 373 7502
Email 59139 0
b.laing@auckland.ac.nz
Contact person for scientific queries
Name 59140 0
Ms Bobbi Laing
Address 59140 0
Discipline of Nutrition and Dietetics
Faculty of Medical and Health Sciences,
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 59140 0
New Zealand
Phone 59140 0
+64 9 9237528
Fax 59140 0
: +64 9 373 7502
Email 59140 0
b.laing@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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