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Strategies to Reduce Iron Deficiency

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02245321
Acronym
STRIDE
Enrollment
702
Registered
2014-09-19
Start date
2011-06-30
Completion date
2014-06-30
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Keywords

hemoglobin recovery, iron recovery, iron supplements

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.

Interventions

DIETARY_SUPPLEMENTFerrous gluconate- 19 mg

Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).

DIETARY_SUPPLEMENTFerrous gluconate- 38 mg

Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).

OTHERLetter Group- Information Provided

Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.

OTHERLetter - No Information Provided

Receive a letter thanking the participant for their participation.

DIETARY_SUPPLEMENTPlacebo

Receive pills to take daily that contain 0 mg iron.

Sponsors

Versiti Blood Health
CollaboratorOTHER
American National Red Cross
CollaboratorOTHER
The Institute for Transfusion Medicine
CollaboratorUNKNOWN
Westat
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin (HgB)Change from baseline in HgB over 2 yearsa protein responsible for transporting oxygen in the blood

Secondary

MeasureTime frameDescription
Soluble transferrin receptor (sTfR)Change from baseline in sTfR over 2 yearsa protein receptor that is used as a measure of functional iron status and the investigation of iron deficiency anemia
Laboratory Hematology resultsChange from baseline in Laboratory hematology results over 2 years.Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)
FerritinChange from baseline in ferritin over 2 yearsa protein that stores iron and releases it when your body needs it

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026