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Trial registered on ANZCTR


Registration number
ACTRN12612000911897
Ethics application status
Approved
Date submitted
1/08/2012
Date registered
27/08/2012
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Monitoring of iron status and clinical evaluation of interventions intended to maintain clinically adequate iron status in women who are new blood donors
Scientific title
In women who are new blood donors, does intervention by the NZ Blood Service with either diet advice or carbonyl iron supplementation, help to maintain iron status
Secondary ID [1] 280980 0
Nil known
Universal Trial Number (UTN)
U1111-1133-1610
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of low iron status and iron deficiency in new female blood donors 287044 0
Condition category
Condition code
Blood 287371 287371 0 0
Anaemia
Oral and Gastrointestinal 287372 287372 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intervention groups of new women blood donors who have been tested at the first blood donation and found to have a ferritin level of 12-25 micrograms/L and are age 18-60 years (inclusive), will be monitored for iron status, donor return rate and interdonation interval between the second and third whole blood donations.

At the second whole blood donation:
Group 1: will be offered a 30 day course of a nutritional iron supplement (18mg carbonyl iron tablets) at a dose of one tablet daily over a 30 day period, or one tablet daily until finished if some days are omitted for any reason. (The 18mg dose size of carbonly iron is registered as a nutritional supplement in New Zealand; it is not registered as a medicine.)
Group 2: will receive verbal and written dietary advice to enhance iron intake by increasing awareness of food choices that may increase their intake of available food iron. The intervention will occur on one occasion at the donor confidential interview before giving the second blood donation.

All participating donors will be tested for ferritin status at the first, second and third whole blood donations. At the second donation. the donors in the two intervention groups will be informed of their iron status test result at their first donation and the significance of the result. As part of each intervention the donors will be informed that their iron status was borderline or low normal and that intervention to boost iron intake is recommended.
Intervention code [1] 285382 0
Lifestyle
Intervention code [2] 285383 0
Treatment: Drugs
Intervention code [3] 285530 0
Prevention
Comparator / control treatment
The control group will have no intervention. Standard procedures for collecting a whole blood donation will occur at the second and third whole blood donations. Donors will not be informed of the result of iron status test results at the first donation.
Control group
Active

Outcomes
Primary outcome [1] 287646 0
% with serum ferritin >20 micrograms/L.
Timepoint [1] 287646 0
at the time the donors give their third whole blood donation.
Primary outcome [2] 287647 0
% with serum ferritin >12 micrograms/L.
Timepoint [2] 287647 0
at the time the donors give their third whole blood donation.
Secondary outcome [1] 298576 0
% who give their third whole blood donation within 12 months of the second donation.
Timepoint [1] 298576 0
For each donor who gives a second donation within 12 months of the first donation, whether or not a third whole blood donation is given within 12 months.
Secondary outcome [2] 298577 0
The interdonation interval between the second and third whole blood donations.
Timepoint [2] 298577 0
For each donor who gives second and third donations within twelve months of the previous donation, the dates on which the second and third whole blood donations were donated.
Secondary outcome [3] 298578 0
The number of call-up requests to donors to give their third whole blood donation.
Timepoint [3] 298578 0
For each donor who gives second and third donations within twelve months of the previous donation, the date on which the the donor gives their third whole blood donation.

Eligibility
Key inclusion criteria
Accepted as a whole blood donor at the time of the first and second whole blood donations and attending with the intention of giving a third donation within 12 months of the previous donation;

Donors at specified major donor centres;

Ferritin test on a blood sample collected at the time of the first blood donation: 12 - 30 micrograms/L (inclusive).

Recruitment of women first time donors into the Iron Study has been extended from those donating at fixed donor centres to also include mobile collection venues, other than Schools.
Minimum age
18 Years
Maximum age
60 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male donors

Female donors who are age 16-17 years or beyond 61st birthday.

Any donor who donates the first and, or second whole blood donation at a Donor Site other than those selected for the study.

Female donors who do not return to give their second whole blood donation within 12 months of the first donation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed consent to participate will be obtained at the confidential routine donor interview before the first whole blood donation is collected.

Allocation to one of the two intervention arms, or the control arm of the study will be determined by the week on which each donor presents to give the second whole blood donation.

A randomised allocation that lists the weeks on which each intervention or control procedure is to be applied will be provided to each participating Donor Collection Site. All donors who attend on that day will have the same intervention or control procedure. It is expected that donor accrual will require 12 months to achieve the donor numbers required.

Details of which intervention or control arm will apply in each week will be provided to the Donor Centres late in the previous week.

Note 1.: Blood Service Staff who manage and arrange donor appointments will not have access to information about which female donors are included or excluded from the Study. They will also not have access to information qbout which intervention or control treatment is to be applied on particular weeks.
Note 2: Only a small minority of donors attending on any one day to donate blood will be included in the Study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In each week of the study all eligible donors (ie those donors returning to give their second donation) will enter the same intervention or control arm. Allocation of each week of the study to one of the three study arms will occur using a stratified randomisation procedure:
1. The period during which donors will give their second donations has been divided into 3 week periods.
2. The three interventions, ie Control, Iron supplementation and Diet advice, can be arranged in six different sequences. The six possible sequences were identified and coded numerically.
3. Randomisation was undertaken by generating a sequence of 34 random numbers from 0 to <1 using Microsoft Excel. The sequence of numbers was then divided into six equal parts based on numerical value.
4. The six sequence codes for the three interventions were allocated to the random number sequence, depending on the value of the random number.
5. The procedure was repeated seven times and the allocation sequence that provided the lowest variance (var=1.2) for utilising all of the six intervention sequences was selected.

This randomisation approach was adopted to minimise bias that might arise from incorrect application of randomisation within Blood Donor Centres if donor staff had scope to apply all of the three interventions on any one day. It was also designed to avoid bias from the known substantial variation in numbers of donors who attend on different days of the week.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4455 0
New Zealand
State/province [1] 4455 0

Funding & Sponsors
Funding source category [1] 285737 0
Other
Name [1] 285737 0
New Zealand Blood Service
Address [1] 285737 0
11 Great South Rd
Epsom
Private Bag 92-071
Auckland 1142
Country [1] 285737 0
New Zealand
Primary sponsor type
Individual
Name
Dr James M Faed
Address
Transfusion Medicine Specialist
Dunedin Hospital Blood Bank
NZ Blood Service
PO Box 6133
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 284564 0
Individual
Name [1] 284564 0
Dr Peter Flanagan
Address [1] 284564 0
National Medical Director
NZ Blood Service
11 Great South Rd
Epsom
Private Bag 92-071
Auckland 1142
Country [1] 284564 0
New Zealand
Other collaborator category [1] 276993 0
Individual
Name [1] 276993 0
Ms Christine van Tilburg
Address [1] 276993 0
Technical Services Business Development Manager
NZ Blood Service
71 Great South Rd
Epsom
Private Bag 92-071
Auckland 1142
Country [1] 276993 0
New Zealand
Other collaborator category [2] 276994 0
Individual
Name [2] 276994 0
Dr Krishna Badami
Address [2] 276994 0
Transfusion Medicine Specialist
NZ Blood Service
Riccarton Rd
PO Box 4156
Christchurch 8011
Country [2] 276994 0
New Zealand
Other collaborator category [3] 276995 0
Individual
Name [3] 276995 0
Dr Richard Charlewood
Address [3] 276995 0
Transfusion Medicine Specialist
NZ Blood Service
71 Great South Rd
Epsom
Private Bag 92-071
Auckland 1142
Country [3] 276995 0
New Zealand
Other collaborator category [4] 276997 0
Individual
Name [4] 276997 0
Dr Dhana Gounder
Address [4] 276997 0
Transfusion Medicine Specialist
NZ Blood Service
71 Great South Rd
Epsom
Private Bag 92-071
Auckland 1142
Country [4] 276997 0
New Zealand
Other collaborator category [5] 276998 0
Individual
Name [5] 276998 0
Dr Anup Chand
Address [5] 276998 0
Medical Officer
NZ Blood Service
71 Great South Rd
Epsom
Private Bag 92-071
Auckland 1142
Country [5] 276998 0
New Zealand
Other collaborator category [6] 276999 0
Individual
Name [6] 276999 0
Dr Deepak Sadani
Address [6] 276999 0
Transfusion Medicine Specialist
NZ Blood Service
PO Box 185
Waikato Mail Centre
Hamilton 3240
Country [6] 276999 0
New Zealand
Other collaborator category [7] 277000 0
Individual
Name [7] 277000 0
Dr Allanah Kilfoyle
Address [7] 277000 0
Haematologist & Transfusion Medicine Specialist
NZ Blood Service
Palmerston North Hospital
PO Box 2056
Palmerston North 4440
Country [7] 277000 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287745 0
New Zealand Multiregion Ethics Committee
Ethics committee address [1] 287745 0
1 The Terrace
PO Box 5013
Wellington 6145

hdecs@moh.govt.nz
Ethics committee country [1] 287745 0
New Zealand
Date submitted for ethics approval [1] 287745 0
Approval date [1] 287745 0
30/07/2012
Ethics approval number [1] 287745 0
MEC/11/12/097

Summary
Brief summary
The study will provide information needed for the New Zealand Blood Service to develop a strategy that will deal effectively with issue of impaired iron status and iron deficiency in some female blood donors. This is an important problem because of the potential for adverse effects on donor health and secondly because of loss of donors from the active donor panel. No commonly agreed strategies exist in international practice for Blood Services to deal with these problems which involve a complex set of interrelated issues. These include: dietary patterns and overall iron status in females in the community, the amount of iron in each whole blood donation, the frequency of donor call-up to donate, the use of tests to assess donor iron status and the scope for low risk iron intervention strategies that are acceptable to the blood donor community and are demonstrably effective.

The study will evaluate the effect of two interventions: firstly, iron replacement using a product that is available as a registered nutritional supplement. This product will provide partial replacement of the iron in each blood donation. The second approach will assess the impact of written and verbal dietary advice.

The study will evaluate the effect on iron status from the interventions in a cohort of female new donors together with the effect of the interventions on return rates to give further donations by the donors.

NZ Blood Service expects to develop strategies for donor iron status testing and for donor iron support from information obtained in this study and in other recent research on iron status in NZ blood donors.
Trial website
Trial related presentations / publications
Insights From A Donor Intervention Trial To Manage Low Iron Status In New Female Donors.
JM Faed, American Association of Blood Banks Annual Scientific Meeting 2015, Transfusion 2015, 55:S3,96A, SP111
Public notes

Contacts
Principal investigator
Name 34515 0
Dr James M Faed
Address 34515 0
Blood Bank, Dunedin Hospital, PO Box 6133, Dunedin 9059
Country 34515 0
New Zealand
Phone 34515 0
+64 (0)3 4709364
Fax 34515 0
Email 34515 0
jim.faed@nzblood.co.nz
Contact person for public queries
Name 17762 0
Dr James M Faed
Address 17762 0
Blood Bank, Dunedin Hospital, PO Box 6133, Dunedin 9059
Country 17762 0
New Zealand
Phone 17762 0
+64 (0)3 4709364
Fax 17762 0
+64 (0)3 4709513
Email 17762 0
jim.faed@nzblood.co.nz
Contact person for scientific queries
Name 8690 0
Dr Dr James M Faed
Address 8690 0
Blood Bank, Dunedin Hospital, PO Box 6133, Dunedin 9059
Country 8690 0
New Zealand
Phone 8690 0
+64 (0)3 4709364
Fax 8690 0
+64 (0)3 470 9513
Email 8690 0
jim.faed@nzblood.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary