Clinical trial NCT02245321: Strategies to Reduce Iron Deficiency
Official title: Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: hemoglobin recovery
iron recovery
iron supplements
Lead sponsor: Westat
Sponsor class: OTHER
Collaborators: name: Versiti
name: American National Red Cross
name: The Institute for Transfusion Medicine
First posted: 2014-09-19
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of iron deficiency in blood donors has been demonstrated to be a direct consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is priority to implement programs to remediate iron deficiency issues associated with blood donations. To explore this issue, the study's aims to:

1. Determine whether regular blood donors provided with accurate information about their iron status and written recommended courses of action will take steps to prevent/mitigate iron deficiency on their own without being given iron supplements by the blood center; and
2. Determine if two different amounts of iron provided by the blood center will prevent/mitigate iron deficiency in regular blood donors.

To conduct this randomized, placebo controlled study, participant donors will be assigned to one of two arms and followed for a 24 month period. Each subject will provide additional blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.

Under the two study arms, subjects are to be randomized into one of the following five blinded categories:

* Receive a thank you letter after each blood donation.
* Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
* Receive pills to take daily that contain no iron (a placebo or inert pill).
* Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
* Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).

Detailed description: Inclusion Criteria

* Donors who have donated whole blood or double red cells ≥ 2 times in the last 12 months if female, or, ≥ 3 times in the last 12 months if male.
* Commitment to meet the donation frequency requirement for the study for two more years, give a blood sample at each visit, and complete baseline and follow-up surveys.

Exclusion Criteria

* Subjects \< 18 years of age.
* Subjects taking iron supplements (including multivitamins with iron) up to one month prior to enrollment.
* Females who are pregnant or plan to become pregnant in the following 2 years.
* Subjects unwilling to meet the requirements of the study.

Eligibility criteria: Inclusion Criteria:

* Repeat donors who have previously participated in RISE study and have continued to donate at a required frequency (donated whole blood or double red cells ≥ 2 times in the last 12 months if female, or, ≥ 3 times in the last 12 months if male)
* Non-RISE donors who have donated whole blood or double red cells ≥ 2 times in the last 12 months if female, or, ≥ 3 times in the last 12 months if male
* commitment to meet the donation frequency requirement for this study for two more years, give a blood sample at each visit, and complete baseline and follow-up surveys

Exclusion Criteria:

* subjects \< 18 years of age
* subjects taking iron supplements (including multivitamins with iron) up to one month prior to enrollment
* females who are pregnant or plan to become pregnant in the following 2 years
* subjects unwilling to meet the requirements of the study

Primary outcomes:
measure: Hemoglobin (HgB)
timeFrame: Change from baseline in HgB over 2 years
Secondary outcomes:
measure: Ferritin
timeFrame: Change from baseline in ferritin over 2 years
measure: Soluble transferrin receptor (sTfR)
timeFrame: Change from baseline in sTfR over 2 years
measure: Laboratory Hematology results
timeFrame: Change from baseline in Laboratory hematology results over 2 years.
Other outcomes:
Locations:
city: Farmington
country: United States
facility: American Red Cross, Connecticut Region
state: Connecticut
city: Rockville
country: United States
facility: Westat
state: Maryland
city: Pittsburgh
country: United States
facility: The Institute for Transfusion Medicince
state: Pennsylvania
city: Milwaukee
country: United States
facility: BloodCenter of Wisconsin
state: Wisconsin
Study officials:
affiliation: BloodCenters of Wisconsin
name: Alan Mast, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bialkowski W, Kiss JE, Wright DJ, Cable R, Birch R, D'Andrea P, Bryant BJ, Spencer BR, Mast AE. Estimates of total body iron indicate 19 mg and 38 mg oral iron are equivalent for the mitigation of iron deficiency in individuals experiencing repeated phlebotomy. Am J Hematol. 2017 Sep;92(9):851-857. doi: 10.1002/ajh.24784. Epub 2017 Jun 9.
citation: Chansky MC, King MR, Bialkowski W, Bryant BJ, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Mast AE. Qualitative assessment of pica experienced by frequent blood donors. Transfusion. 2017 Apr;57(4):946-951. doi: 10.1111/trf.13981. Epub 2017 Feb 5.
citation: Mast AE, Bialkowski W, Bryant BJ, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR. A randomized, blinded, placebo-controlled trial of education and iron supplementation for mitigation of iron deficiency in regular blood donors. Transfusion. 2016 Jun;56(6 Pt 2):1588-97. doi: 10.1111/trf.13469. Epub 2016 Jan 26.
citation: Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.