None listed
Conditions
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.
Interventions
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. D
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.
Sponsors
Australian Red Cross Blood Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
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 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
Outcome results
None listed