Strategies to Reduce Iron Deficiency

Study Overview
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Brief Summary
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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: 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 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
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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.

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

Conditions
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Iron Deficiency

Intervention / Treatment
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* Dietary Supplement: Ferrous gluconate- 19 mg
* Dietary Supplement: Ferrous gluconate- 38 mg
* Other: Letter Group- Information Provided
* Other: Letter - No Information Provided
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (HgB) | 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 | 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) | 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 | Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH) | Change from baseline in Laboratory hematology results over 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemoglobin recovery, iron recovery, iron supplements