Monitoring of iron status and clinical evaluation of interventions intended to maintain clinically adequate iron status in women who are new blood donors
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
Dr James M Faed
5,100 participants
Jul 8, 2013
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria4
- 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.
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Interventions
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.
Locations(1)
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ACTRN12612000911897