Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
702 participants
INTERVENTIONAL
2011-06-30
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Letter Group- No information
Receive a thank you letter after each blood donation.
Letter - No Information Provided
Receive a letter thanking the participant for their participation.
Letter Group- Information Provided
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
Letter Group- Information Provided
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
Ferrous gluconate- 0 mg
Receive pills to take daily that contain no iron (a placebo or inert pill).
Placebo
Receive pills to take daily that contain 0 mg iron.
Ferrous gluconate- 19 mg
Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
Ferrous gluconate- 19 mg
Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
Ferrous gluconate- 38 mg
Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
Ferrous gluconate- 38 mg
Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ferrous gluconate- 19 mg
Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
Ferrous gluconate- 38 mg
Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
Letter Group- Information Provided
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
Letter - No Information Provided
Receive a letter thanking the participant for their participation.
Placebo
Receive pills to take daily that contain 0 mg iron.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Versiti
OTHER
American National Red Cross
OTHER
The Institute for Transfusion Medicine
UNKNOWN
Westat
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alan Mast, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
BloodCenters of Wisconsin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
American Red Cross, Connecticut Region
Farmington, Connecticut, United States
Westat
Rockville, Maryland, United States
The Institute for Transfusion Medicince
Pittsburgh, Pennsylvania, United States
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1R01HL10580901
Identifier Type: -
Identifier Source: org_study_id