Strategies to Reduce Iron Deficiency (STRIDE)

December 4, 2023 updated by: Westat

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

702

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • American Red Cross, Connecticut Region
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Westat
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15220
        • The Institute for Transfusion Medicince
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • BloodCenter of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Letter Group- No information
Receive a thank you letter after each blood donation.
Other: Letter - No Information Provided
Receive a letter thanking the participant for their participation.
Experimental: Letter Group- Information Provided
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
Other: Letter Group- Information Provided
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
Placebo Comparator: Ferrous gluconate- 0 mg
Receive pills to take daily that contain no iron (a placebo or inert pill).
Dietary supplement: Placebo
Receive pills to take daily that contain 0 mg iron.
Experimental: Ferrous gluconate- 19 mg
Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
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).
Experimental: Ferrous gluconate- 38 mg
Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
Dietary 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin (HgB)
Time Frame: Change from baseline in HgB over 2 years
a protein responsible for transporting oxygen in the blood
Change from baseline in HgB over 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ferritin
Time Frame: Change from baseline in ferritin over 2 years
a protein that stores iron and releases it when your body needs it
Change from baseline in ferritin over 2 years
Soluble transferrin receptor (sTfR)
Time Frame: Change from baseline in sTfR over 2 years
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
Laboratory Hematology results
Time Frame: Change from baseline in Laboratory hematology results over 2 years.
Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)
Change from baseline in Laboratory hematology results over 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Westat

Collaborators

Versiti
American National Red Cross
The Institute for Transfusion Medicine

Investigators

  • Principal Investigator: Alan Mast, MD, PhD, BloodCenters of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimated)

September 19, 2014

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HL10580901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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