Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000586314p
Ethics application status
Not yet submitted
Date submitted
17/04/2017
Date registered
26/04/2017
Date last updated
26/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing the effect of intravenous and oral iron supplementation on the quality of life of inflammatory bowel disease patients with iron deficiency without anaemia
Scientific title
A Prospective, Randomized, Multicentre Study to Evaluate the Effect of Intravenous Iron Infusion Compared with Oral Iron Supplementation on the Quality of Life in Inflammatory Bowel Disease Patients with Non-Anaemic Hypoferritinaemia
Secondary ID [1] 291717 0
None
Universal Trial Number (UTN)
None
Trial acronym
IRonIBDH
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 302897 0
Hypoferritinaemia 302898 0
Condition category
Condition code
Oral and Gastrointestinal 302387 302387 0 0
Inflammatory bowel disease
Diet and Nutrition 302448 302448 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
History taking, physical exam, blood test, stool test are involved in patient selection to ensure suitability by qualified gastroenterologists or gastroenterology trainees. Patient information sheet is provided. Research Nurse specialist or above mentioned clinicians will go through consent form with eligible patients. Consented inflammatory bowel disease patients in remission with low ferritin level without anaemia will then be randomly assigned patients to either treatment with intravenous (Arm 1) or oral iron (Arm 2). All patients will complete two questionnaires at baseline, one on quality of life and the other on fatigue.
Arm 1: one off visit for administration of intravenous Ferric Carboxymaltose (Ferrinject) 1000mg
Arm 2: oral ferrous sulfate 1x 325mg tablet once dailyi for 6 weeks. Tablets will be counted at the end of study to assess adherence.

At the end of six weeks, all patients will be seen by clinicians to assess inflammatory bowel disease activity through history taking, physical exam, blood test. The same questionnaires on quality of life and fatigues will be completed at end of intervention.
Intervention code [1] 297803 0
Treatment: Drugs
Comparator / control treatment
Oral iron supplementation is the control treatment
Control group
Active

Outcomes
Primary outcome [1] 301797 0
Change in the quality of health scores including both Shortened IBD Questionnaire (SIBDQ) and SF 36. This is a composite primary outcome. Both questionnaires assess quality of life. SIBDQ is disease specific to IBD, and SF 36 is a general quality of life questionnaire.
Timepoint [1] 301797 0
6 weeks post intervention
Secondary outcome [1] 333882 0
Change in fatigue score using the Inflammatory Bowel Disease Fatigue Score (IBD-F).
Timepoint [1] 333882 0
Six weeks post intervention
Secondary outcome [2] 334168 0
Disease activity as indicated by Harvey Bradshaw and Simple Colitis Disease Activity Score will be assessed compared to baseline to assess safety of oral iron supplementation (ie if increased risk of flare with oral supplementation)
Timepoint [2] 334168 0
Six weeks post intervention

Eligibility
Key inclusion criteria
1. IBD diagnosed for at least 3 months and disease in remission for at least 3 months indicative by:
- HBAI less or equal to 3 in Crohn’s disease (CD), SCCAI less than or equal to 3 in ulcerative (UC) patients AND
- normal C-reactive protein (< 5)
2. Age greater than 16 years old
3. Ferritin equal or less than 30 ug/L
4. Haemoglobin equal or greater than 130g/L male and equal or greater than 120g/L in females
Minimum age
17 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Macrocytosis indicated by increased mean corpuscular volume (MCV) in the absence of thiopurine use
2. Pregnant or actively trying to conceive
3. Previous oral or IV iron intolerant/allergic
4. Haemoglobinopathy
5. Folate/B12 deficiency
6. Iron overload
7. Current corticosteroid use or change in IBD medications within the last 3 month

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer softwar
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Previously a mean improvement in the main outcome measure (IBDQ) of 20 points (standard deviation 24.8) was seen in non-anaemic patients.. A clinically significant difference in IBDQ improvement between two groups would be considered to be 20 points. This gives a required sample size of 52. Because the original data was non-parametric and potentially skewed an allowance of 10% will be given, resulting in a total target sample size of 58 patients.

Wilcoxon signed rank tests will be used to compare repeated measurements in the groups, before and after treatment, and Mann Whitney U to compare measurements between groups, using the SPSS statistical package.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/05/2017
Actual
Date of last participant enrolment
Anticipated
8/05/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 8825 0
New Zealand
State/province [1] 8825 0

Funding & Sponsors
Funding source category [1] 296217 0
Hospital
Name [1] 296217 0
Hutt Hospital
Country [1] 296217 0
New Zealand
Primary sponsor type
Individual
Name
Dr Stephen Inns
Address
Hutt Hospital. High Street. Lower Hutt 5010.
Country
New Zealand
Secondary sponsor category [1] 295128 0
None
Name [1] 295128 0
Address [1] 295128 0
Country [1] 295128 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297456 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 297456 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 297456 0
New Zealand
Date submitted for ethics approval [1] 297456 0
24/04/2017
Approval date [1] 297456 0
Ethics approval number [1] 297456 0

Summary
Brief summary
The study is to compare the effect of Intravenous Iron Infusion Compared with Oral Iron Supplementation on the Quality of Life in Inflammatory Bowel Disease (IBD) Patients with low iron level without anaemia. The hypothesis is intravenous iron is superior to oral supplementation in improving the quality of life and fatigue of IBD patients. Patients eligible will be randomly assigned to receive either intravenous iron or oral iron for 6 weeks. Questionnaires on quality of life and fatigue will be completed by all participants at the start and 6 weeks after given iron supplementation. The change in the quality of life and fatigue scores will be assessed at the end of the study.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 74090 0
Dr Stephen Inns
Address 74090 0
Hutt Hospital
High Street, Lower Hutt 5010
Country 74090 0
New Zealand
Phone 74090 0
+64 4 566 6999
Fax 74090 0
Email 74090 0
[email protected]
Contact person for public queries
Name 74091 0
Dr Sylvia Wu
Address 74091 0
Hutt Hospital
High Street, Lower Hutt 5010
Country 74091 0
New Zealand
Phone 74091 0
+64 4 566 6999 ext 2782
Fax 74091 0
Email 74091 0
[email protected]
Contact person for scientific queries
Name 74092 0
Dr Sylvia Wu
Address 74092 0
Hutt Hospital
High Street, Lower Hutt 5010
Country 74092 0
New Zealand
Phone 74092 0
+64 4 566 6999 ext 2782
Fax 74092 0
Email 74092 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.