Strategies to Reduce Iron Deficiency

Iron Deficiency Clinical Trial

— STRIDE  

Official title:

Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245321
• Other study ID #: 1R01HL10580901
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: December 2023
• Source: Westat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• 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).

Other:
• 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.

Dietary Supplement:
• Placebo
Receive pills to take daily that contain 0 mg iron.

Locations

Country	Name	City	State
United States	American Red Cross, Connecticut Region	Farmington	Connecticut
United States	BloodCenter of Wisconsin	Milwaukee	Wisconsin
United States	The Institute for Transfusion Medicince	Pittsburgh	Pennsylvania
United States	Westat	Rockville	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Westat	American National Red Cross, The Institute for Transfusion Medicine, Versiti

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View 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 phleb — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin (HgB)	a protein responsible for transporting oxygen in the blood	Change from baseline in HgB over 2 years
Secondary	Ferritin	a protein that stores iron and releases it when your body needs it	Change from baseline in ferritin over 2 years
Secondary	Soluble transferrin receptor (sTfR)	a protein receptor that is used as a measure of functional iron status and the investigation of iron deficiency anemia	Change from baseline in sTfR over 2 years
Secondary	Laboratory Hematology results	Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)	Change from baseline in Laboratory hematology results over 2 years.