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Trial registered on ANZCTR


Registration number
ACTRN12622000412730
Ethics application status
Approved
Date submitted
9/02/2022
Date registered
10/03/2022
Date last updated
14/03/2023
Date data sharing statement initially provided
10/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
IV iron infusion therapy in patients with persistent pain
Scientific title
The efficacy of IntraVenous Iron Therapy in persistent pAin patients with iron deficiency: a randomised controLled trial: The VITAL Trial.
Secondary ID [1] 306340 0
Nil known
Universal Trial Number (UTN)
U1111-1273-9482
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anaemia 325132 0
Chronic pain 325133 0
Condition category
Condition code
Blood 322539 322539 0 0
Anaemia
Anaesthesiology 322680 322680 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be booked into the surgical day care unit (SDCU) at the RBWH or the Tess Cramond Pain and Research Centre at their earliest convenience for the interventional phase of the study. The study drug will be prepared and administered by unblinded study personnel. The intervention consists of a single dose of intravenous ferric derisomaltose 20mg/kg in 100mL normal saline over 30 minutes up to a maximum dose of 1500mg. Clinical monitoring will be conducted in accordance with institutional policies for the delivery of either the interventional arm (IV Iron) or placebo (saline) depending on randomisation allocation.
Intervention code [1] 322771 0
Treatment: Drugs
Comparator / control treatment
100 mL intravenous normal saline infused over 30 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 330337 0
To evaluate and assess participants fatigue levels using a validated survey, the FACIT Fatigue Scale (Version 4) at baseline and then 8-weeks post administration of derismaltose vs placebo.
Timepoint [1] 330337 0
8-weeks post administration of derismaltose or placebo.
Secondary outcome [1] 405859 0
To assess health-related quality of life by measuring 36-Item Short Form Survey (SF-36) (Version 1) at baseline and compare the values 8 weeks post-intervention.
Timepoint [1] 405859 0
8-weeks post administration of derismaltose or placebo.
Secondary outcome [2] 405860 0
To compare and analyse participant pain levels from baseline to 8 weeks post intervention utilising the electronic Persistent Pain Outcome Collaboration (ePPOC) questionnaire (Version 2.0).
Timepoint [2] 405860 0
8-weeks post administration of derismaltose or placebo.
Secondary outcome [3] 406383 0
To measure iron studies parameters from baseline to 8 weeks post-intervention from blood tests taken at both time points as an exploratory outcome.
Timepoint [3] 406383 0
8-weeks post administration of derismaltose or placebo.
Secondary outcome [4] 406665 0
To compare pain medication use at baseline and again 8 weeks post intervention as indicated from patient records and feedback.
Timepoint [4] 406665 0
8-weeks post administration of derismaltose or placebo.

Eligibility
Key inclusion criteria
• Greater than or equal to 18 years
• Patients experiencing pain for more than 12 months
• Patients with confirmed iron deficiency (ferritin <50u/L) with or without anaemia (Hb
<120g/L for females, Hb <130g/L for males)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected blood disorder
• Pregnant
• Known medications with iron supplements including intravenous iron
• Surgery within the previous 6 months
• Inability to provide informed consent due to a diminished understanding or
comprehension, or a language other than English without an interpreter
• Are not on a current treatment plan from the hospital pain clinic

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 concealment will occur using a electronic central randomisation service via REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
To achieve 80% power to detect a medium effect size of 0.5 (Cohen’s d) between trial groups as per Cohen (1998), a sample size of 128 is required. This uses a two-sample equal variance t-test with a significance level of 0.05 (two-sided). Accounting for 20% drop out, the final sample size for recruitment is 160 (80 per group).

Patient characteristics and baseline scores will be described across trial groups using mean (standard deviation) for continuous normally distributed variables, median (interquartile range) for continuous non-normally distributed variables and frequency (percent) for categorical variables. The primary outcome of the change in FACIT-Fatigue score from baseline to 8 weeks post intervention will be compared between placebo and intervention groups using a Student’s T-test. Comparison between these trial groups for normally distributed secondary outcomes will also use a Student’s T-test. Continuous non-normally distributed secondary outcomes will be compared using a Mann-Whitney U test and categorical outcomes using a chi-square test or Fisher’s Exact test as appropriate. Adjustment for baseline levels using methods such as ANCOVA or logistic regression will be performed as secondary analyses. All tests will be indicated as statistically significant if their p-value is less than 0.05 (two-sided).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21670 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 36717 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 310692 0
Commercial sector/Industry
Name [1] 310692 0
Pharmacosmos International
Country [1] 310692 0
Denmark
Primary sponsor type
Hospital
Name
Metro North Health Services Royal Brisbane and Women's Hospital
Address
Butterfield Street,
Herston. Queensland. 4029
Country
Australia
Secondary sponsor category [1] 312036 0
None
Name [1] 312036 0
Address [1] 312036 0
Country [1] 312036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310278 0
Royal Brisbane and Women's Hospital Human Research and Ethics Committee
Ethics committee address [1] 310278 0
Butterfield Street,
Herston. Queensland. 4029.
Ethics committee country [1] 310278 0
Australia
Date submitted for ethics approval [1] 310278 0
09/03/2022
Approval date [1] 310278 0
24/06/2022
Ethics approval number [1] 310278 0
HREC/2022/QRBW/77253;

Summary
Brief summary

Patients with persistent or chronic pain often have underlying chronic conditions that can be overlooked such as anaemia, which can have significant effect on the quality of life of patients. A recent pilot study involving patients who have persistent pain for greater than 12 months have shown that 59% have iron deficiency. This study will follow on from the pilot study to examine if intravenous iron infusions do improve this cohort of patients fatigue levels, their health-related quality of life, pain levels and reduce pain medication use.
This study will be conducted at a Quaternary hospital in Brisbane as a single-site, single-blinded, parallel-group randomised controlled trial. We plan to recruit 160 participants who will be randomised to receive either intravenous iron infusion or placebo. The outcomes will be measured using specific validated surveys and questionnaires related to fatigue (FACIT), health-related quality of life (SF-36) and pain (ePPOC).


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117098 0
A/Prof Kerstin Wyssusek
Address 117098 0
Department of Anaesthesia and Perioperative Medicine,
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston. Queensland. 4029.
Country 117098 0
Australia
Phone 117098 0
+61 7 3646 3104
Fax 117098 0
+61 7 3646 1308
Email 117098 0
[email protected]
Contact person for public queries
Name 117099 0
Kerstin Wyssusek
Address 117099 0
Department of Anaesthesia and Perioperative Medicine,
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston. Queensland. 4029.
Country 117099 0
Australia
Phone 117099 0
+61 7 3646 3104
Fax 117099 0
+61 7 3646 1308
Email 117099 0
[email protected]
Contact person for scientific queries
Name 117100 0
Greg Anderson
Address 117100 0
Iron Metabolism Laboratory,
QIMR Berghofer Medical Research Institute,
300 Herston Road,
Brisbane, QLD 4006.
Country 117100 0
Australia
Phone 117100 0
+61 7 3362 0187
Fax 117100 0
Email 117100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15007Informed consent form    Patients will be provided with the Patient Informa... [More Details]
15008Ethical approval    HREC approval letter. This will be supplied and at... [More Details]
15107Other    PICF with HREC and Governance (site) approvals wil... [More Details]



Results publications and other study-related documents

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