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NCT Number: NCT02245321

Strategies to Reduce Iron Deficiency

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).

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Red Cross, Connecticut Region, Farmington, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous gluconate- 19 mg

Dietary Supplement

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

Ferrous gluconate- 38 mg

Dietary Supplement

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

Letter Group- Information Provided

Other

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

Letter - No Information Provided

Other

Receive a letter thanking the participant for their participation.

Placebo

Dietary Supplement

Receive pills to take daily that contain 0 mg iron.

Primary outcomes

  1. Hemoglobin (HgB)

    Time frame: Change from baseline in HgB over 2 years

    a protein responsible for transporting oxygen in the blood

Secondary outcomes

  1. Ferritin

    Time frame: Change from baseline in ferritin over 2 years

    a protein that stores iron and releases it when your body needs it

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Westat

Other

Collaborators

  • American National Red Cross
  • The Institute for Transfusion Medicine
  • Versiti Blood Health

Registry information

Official study title

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

Acronym: STRIDE

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2014
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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