The Donor Iron Replacement Study; a study of post-donation oral iron supplementation in female whole blood donors aged 18-45 years

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001078640
• Date of registration: 09/10/2014
• Prospective Registration: No
• Primary sponsor: Australian Red Cross Blood Service
• 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.
• Date of first enrolment: 07/10/2014
• Target sample size: 720
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001078640.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Joanna Speedy

• Name: Dr Joanna Speedy

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Iron deficiency;Anaemia;
Iron deficiency
Anaemia

Blood - Anaemia

Intervention(s)

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.

Primary Outcome(s)

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.[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.

]

Donor acceptance/compliance measured by survey responses. The survey has been specifically designed for this study.
[Surveys 4 weeks following:
- recruitment visit
- 8-13 month visit ]

Secondary Outcome(s)

Efficacy in maintaining iron stores using change in serum ferritin


[Ferritin measured at baseline and 8-13 months
]

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. [Surveys 4 weeks following
a. recruitment visit and
b. 8-13 month visit ]

Safety - proportion of donors with ferritin above reference range in those with previously normal iron stores
[Ferritin measured at baseline and 8-13 months]

Efficacy in reducing deferrals due to low haemoglobin (screening haemoglobin) compared with other available internal historical data using[screening Hb collected 8-13 month visit ]

Efficacy in maintaining haemoglobin using change in haemoglobin from baseline to 8-13 month visit[Hb measured at recruitment and again at 8-13 month visit]

Efficacy in reducing iron deficiency at 8-13 month visit compared with other available internal historical data [Ferritin collected at 8-13 month visit ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Australian governments fund the Australian Red Cross Blood Service via the National Blood Authority.

Ethics review

Status: Approved
Approval date:
Contact:

Australian Red Cross Blood Service Human Research Ethics Committee