Strategies to Reduce Iron Deficiency (STRIDE)

Westat

Status: Completed

Conditions: Iron Deficiency

Treatments: Other: Letter Group- Information Provided; Dietary Supplement: Ferrous gluconate- 38 mg; Dietary Supplement: Ferrous gluconate- 19 mg; Other: Letter - No Information Provided; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02245321

1R01HL10580901

Details and patient eligibility

About

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).

Full 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.

Enrollment: 702 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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702 participants in 5 patient groups, including a placebo group

Letter Group- No information

Placebo Comparator group

Description:

Receive a thank you letter after each blood donation.

Treatment:

Other: Letter - No Information Provided

Letter Group- Information Provided

Experimental group

Description:

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

Treatment:

Other: Letter Group- Information Provided

Ferrous gluconate- 0 mg

Placebo Comparator group

Description:

Receive pills to take daily that contain no iron (a placebo or inert pill).

Treatment:

Dietary Supplement: Placebo

Ferrous gluconate- 19 mg

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ferrous gluconate- 19 mg

Ferrous gluconate- 38 mg

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ferrous gluconate- 38 mg