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Trial registered on ANZCTR


Registration number
ACTRN12614001078640
Ethics application status
Approved
Date submitted
1/10/2014
Date registered
9/10/2014
Date last updated
1/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Donor Iron Replacement Study; a study of post-donation oral iron supplementation in female whole blood donors aged 18-45 years
Scientific title
Pilot program to determine operational feasibility, donor acceptance and efficacy of post-donation oral iron supplementation in female whole blood donors aged 18-45 years who make two or more whole blood donations in a year.
Secondary ID [1] 285425 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
The DIRECT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 293179 0
Anaemia 293180 0
Condition category
Condition code
Blood 293473 293473 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to take a course of oral iron supplements after each whole blood donation (on up to a maximum of three occasions) during the 13 month study period.
To access iron supplements donors select one of the following:
1. Delivery of a packet of Ferro-tab from a participating pharmacy at no cost to the participant. Dose one tablet (65.7 mg elemental iron) per day for 20 days.
2. Collection of a packet of Ferro-tab from a participating pharmacy at no cost to the participant. Dose one tablet (65.7 mg of elemental iron) per day for 20 days.
3. Purchase one of the following iron supplements from a pharmacy at their own cost:
Ferro-tab: dose - one tablet daily for 20 days (65.7 mg elemental iron per day)
Ferro Gradumet: dose - one tablet a day for 14 days (105 mg elemental iron per day)
Ferro-Grad C: dose - one tablet a day for 14 days (105 mg elemental iron per day)
Adherence will be determined from surveys distributed to donors 4 weeks after their recruitment visit and their 8-13 month visit (if applicable).
Donors are not required to record the number of tablets taken or return unused tablets.
Intervention code [1] 290346 0
Prevention
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293275 0
Donor acceptance/compliance measured by survey responses. The survey has been specifically designed for this study.
Timepoint [1] 293275 0
Surveys 4 weeks following:
- recruitment visit
- 8-13 month visit
Primary outcome [2] 293276 0
Operational feasiblity measured by time and motion studies and staff surveys.
The time and motion will record the time taken for the donor reception and interview process. A timer will start immediately after the donor has been asked by reception staff to complete their paperwork. The time is then noted when the donor is taken into the interview room and then noted again at completion of the interview.
The staff survey has been specifically designed for this study.
Timepoint [2] 293276 0
Time and motion studies - performed at baseline and 4-6 months following commencement of study
Staff Survey - conducted at 4-6 months and completion of study.

Secondary outcome [1] 310701 0
Efficacy in maintaining iron stores using change in serum ferritin
Timepoint [1] 310701 0
Ferritin measured at baseline and 8-13 months
Secondary outcome [2] 310702 0
Safety - proportion of donors with ferritin above reference range in those with previously normal iron stores
Timepoint [2] 310702 0
Ferritin measured at baseline and 8-13 months
Secondary outcome [3] 310703 0
Safety - number and type of adverse events and degree of concern reported by donors
Specific adverse events will be captured as reported by the donor - donors are not provided with categories/selection of adverse events but are requested to describe the symptom(s). The outcomes will report on the frequency of reports for specific symptoms -e.g constipation, nausea, diarrhoea
Adverse events will be assessed based on donor responses to survey questions including how concerned they were, whether treatment was required and whether medical advice was sought.
Timepoint [3] 310703 0
Surveys 4 weeks following
a. recruitment visit and
b. 8-13 month visit
Secondary outcome [4] 310753 0
Efficacy in maintaining haemoglobin using change in haemoglobin from baseline to 8-13 month visit
Timepoint [4] 310753 0
Hb measured at recruitment and again at 8-13 month visit
Secondary outcome [5] 310754 0
Efficacy in reducing iron deficiency at 8-13 month visit compared with other available internal historical data
Timepoint [5] 310754 0
Ferritin collected at 8-13 month visit
Secondary outcome [6] 310755 0
Efficacy in reducing deferrals due to low haemoglobin (screening haemoglobin) compared with other available internal historical data using
Timepoint [6] 310755 0
screening Hb collected 8-13 month visit

Eligibility
Key inclusion criteria
-Females aged 18-45 (inclusive) on the day of recruitment
-Eligible and intending to donate whole blood on the day of recruitment
-Have made at least one whole blood donation (300mL or more) in the last 12 months
-Able to provide written consent
- Able to receive, collect or purchase an iron supplement as per the study options
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Therapeutic donors
Autologous donors
Donors who are ineligible to donate on the day of recruitment
Donors converted to apheresis on the day of the recruitment visit;
Donors with any of the following:
-A history of allergy to iron supplements
-A history of hereditary haemochromatosis, iron overload or a known genetic predisposition to these conditions.
-An immediate family history of haemochromatosis (and have not been tested to exclude genetic predisposition to the condition); or
-Red cell disorders (i.e. polycythaemia, thalassaemia trait, sickle cell trait, G6PD deficiency, hereditary spherocytosis, hereditary elliptocytosis;
- history of inflammatory bowel disease, bowel malignancy, colonic polyps,
Donors using iron supplements on the advice of their doctor

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prospective participants are advised that the study involves the use of oral iron supplements, surveys, ferritin testing and collection of non-identifying data.
All participants are requested to select from one of the following options:
- Delivery of Ferro-tab to their nominated address (free of charge)
-Collection of Ferro-tab from a participating pharmacy (free of charge) or if preferred
- Purchase a supplement from the following list at their own expense from a pharmacy of their choice:
- Ferro-tab
-Ferro-Gradumet or
-Ferro-Grad C
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
1. Descriptive data obtained through participant follow-up surveys will include the proportion (%) of participants who:
a. Commenced the course of iron supplements;
b. Were compliant (took >75% of the recommended course);
c. Experienced side effects from use of iron supplements; and
d. Would take it again.

2.Efficacy of iron replacement data:
a. Change in geometric mean ferritin from baseline to 8-13 months (t-test);
b. Change in Hb concentration from baseline to 8-13 months (t test);
c. Change in prevalence of iron deficiency from baseline to
8-13 months (test of proportions);
d. Comparison of prevalence of iron deficiency between baseline and 8-13 months and also the prevalence data from the 2012 Iron Depletion Prevalence Study, the READ Study and other internal and external studies as appropriate(test of proportions); and
e. Change in donor return rates from historical data in comparison to the study period.

3.Operational feasibility data:
a. Change in time to complete donor interview from baseline to 4-6 months; and
b. Proportion (%) of staff who felt the increase in workload was unacceptably high.
Data may be stratified by site if required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2014
Actual
7/10/2014
Date of last participant enrolment
Anticipated
28/12/2014
Actual
19/12/2014
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
720
Accrual to date
Final
768
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8737 0
5000 - Adelaide
Recruitment postcode(s) [2] 8749 0
5015 - Port Adelaide
Recruitment postcode(s) [3] 8750 0
5097 - Ridgehaven
Recruitment postcode(s) [4] 8751 0
5046 - Oaklands Park
Recruitment postcode(s) [5] 8752 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 290030 0
Government body
Name [1] 290030 0
Australian governments fund the Australian Red Cross Blood Service via the National Blood Authority.
Country [1] 290030 0
Australia
Primary sponsor type
Other
Name
Australian Red Cross Blood Service
Address
417 St Kilda Rd, Melbourne VIC
3004
Country
Australia
Secondary sponsor category [1] 288722 0
None
Name [1] 288722 0
Address [1] 288722 0
Country [1] 288722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291737 0
Australian Red Cross Blood Service Human Research Ethics Committee
Ethics committee address [1] 291737 0
17 O'Riordan Street
Alexandria
NSW
2015
Ethics committee country [1] 291737 0
Australia
Date submitted for ethics approval [1] 291737 0
Approval date [1] 291737 0
26/08/2014
Ethics approval number [1] 291737 0
2014#13

Summary
Brief summary
Approximately 220-250 mg of iron is lost with each 470 mL whole blood donation. This may result in progressive iron deficiency, ultimately leading to iron deficiency anaemia and deferral at a subsequent attendance. This study will investigate the use of oral iron supplments after whole blood donation in women aged 18-45 years who make two or more whole blood donations in a year. Participants will be followed for a period of 13 months and asked to take iron supplements after each whole blood donation during that time (up to a maximum of three occasions during the study period). Donors will be provided with the following options to assist with access to a suitable iron supplement:
- having the iron supplied by a pharmacy (at no cost to the donor) or
-if preferred by the donor purchasing a supplement at their own cost from any pharmacy from a list of suitable supplements provided by the Blood Service.
Participants are not required to donate at certain timepoints.
Participants will have ferritin samples collected at baseline and again 8-13 months (if applicable) after their recruitment visit. Participants will be asked to complete up to two surveys.
The study will evaluate donor acceptance, efficacy and operational feasiblity.
Trial website
Trial related presentations / publications
Public notes
The study will be recruiting at all fixed blood centre collection centres in South Australia and from select mobile unit locations.

Contacts
Principal investigator
Name 51806 0
Dr Anthony Keller
Address 51806 0
Australian Red Cross Blood Service Level 1, 69 Walters Drive, Osborne Park WA 6017
Country 51806 0
Australia
Phone 51806 0
61 (08) 6213 5914
Fax 51806 0
Email 51806 0
[email protected]
Contact person for public queries
Name 51807 0
Joanna Speedy
Address 51807 0
Australian Red Cross Blood Service 301 Pirie Street, Adelaide SA 5000
Country 51807 0
Australia
Phone 51807 0
61 (08) 8112 1389
Fax 51807 0
Email 51807 0
[email protected]
Contact person for scientific queries
Name 51808 0
Joanna Speedy
Address 51808 0
Australian Red Cross Blood Service 301 Pirie Street, Adelaide SA 5000
Country 51808 0
Australia
Phone 51808 0
61 (08) 8112 1389
Fax 51808 0
Email 51808 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

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