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Iron REplacement ADvice Study in female donors aged 18-45 years

The acceptance and feasibility of iron replacement advice for female whole blood donors aged 18-45 years.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000430639
Acronym
READ Study
Enrollment
1404
Registered
2014-04-28
Start date
2014-04-14
Completion date
2014-09-06
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 pilot an education program for high risk donors on how to replenish iron stores after donation. The study will evaluate operational feasibility, donor acceptance and efficacy of this program.

Interventions

Consented participants will be provided with a brochure prior to their donation which provides advice on how to replenish iron stores after a whole blood donation. The information is provided at each eligible visit during the study period. Adherence and acceptability will be monitored using a specifically designed questionnaire at 6 weeks after the recruitment visit and again 6 weeks after the 11-13 month visit if the donor attends at this time. Donors are provided with a study contact number

Consented participants will be provided with a brochure prior to their donation which provides advice on how to replenish iron stores after a whole blood donation. The information is provided at each eligible visit during the study period. Adherence and acceptability will be monitored using a specifically designed questionnaire at 6 weeks after the recruitment visit and again 6 weeks after the 11-13 month visit if the donor attends at this time. Donors are provided with a study contact number to assist with any queries that may arise after they leave the donor centre.

Sponsors

Australian Red Cross Blood Service
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

-Females aged 18-45 (inclusive) on the day of recruitment -Eligible and intending to donate whole blood -Made at least one whole blood donation (>300mL) in the last -12 months -Able to provide written consent

Exclusion criteria

Therapeutic donors Autologous donors Donors who are ineligible to donate (including Hb-related deferrals) Donors converted to apheresis on the day of the recruitment visit; and 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. -A family history of haemochromatosis (and have not been tested to exclude genetic predisposition to the condition); or -Red cell disorders (i.e. thalassaemia trait, sickle cell trait, G6PD deficiency, hereditary spherocytosis, hereditary elliptocytosis)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026