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

Not Applicable

Completed

• Conditions: Iron deficiency; Anaemia; Blood - Anaemia

• Registration Number: ACTRN12614001078640
• Lead Sponsor: Australian Red Cross Blood Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 720

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Donor acceptance/compliance measured by survey responses. The survey has been specifically designed for this study.<br>[Surveys 4 weeks following:<br>- recruitment visit<br>- 8-13 month visit ];Operational feasiblity measured by time and motion studies and staff surveys.<br>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.<br>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<br>Staff Survey - conducted at 4-6 months and completion of study. <br><br>]