Strategies to Reduce Iron Deficiency

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).

Conditions

• Iron Deficiency

Interventions

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).

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).

OTHER

Letter Group- Information Provided

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

OTHER

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.

Sponsors & Collaborators

• Versiti

  collaborator OTHER

• American National Red Cross

  collaborator OTHER

• The Institute for Transfusion Medicine

  collaborator UNKNOWN

• Westat

  lead OTHER

Principal Investigators

• Alan Mast, MD, PhD · BloodCenters of Wisconsin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2014-05-31

Completion

2014-06-30

Countries

• United States

Study Locations