Strategies to Reduce Iron Deficiency
- Conditions
- Iron Deficiency
- Interventions
- Other: Letter Group- Information ProvidedDietary Supplement: PlaceboDietary Supplement: Ferrous gluconate- 19 mgDietary Supplement: Ferrous gluconate- 38 mgOther: Letter - No Information Provided
- Registration Number
- NCT02245321
- Lead Sponsor
- Westat
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 702
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letter Group- Information Provided Letter Group- Information Provided Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation. Ferrous gluconate- 0 mg Placebo Receive pills to take daily that contain no iron (a placebo or inert pill). Ferrous gluconate- 19 mg Ferrous gluconate- 19 mg Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron). Ferrous gluconate- 38 mg Ferrous gluconate- 38 mg Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement). Letter Group- No information Letter - No Information Provided Receive a thank you letter after each blood donation.
- Primary Outcome Measures
Name Time Method Hemoglobin (HgB) Change from baseline in HgB over 2 years a protein responsible for transporting oxygen in the blood
- Secondary Outcome Measures
Name Time Method Ferritin Change from baseline in ferritin over 2 years a protein that stores iron and releases it when your body needs it
Soluble transferrin receptor (sTfR) 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
Laboratory Hematology results Change from baseline in Laboratory hematology results over 2 years. Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)
Trial Locations
- Locations (4)
BloodCenter of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Westat
🇺🇸Rockville, Maryland, United States
American Red Cross, Connecticut Region
🇺🇸Farmington, Connecticut, United States
The Institute for Transfusion Medicince
🇺🇸Pittsburgh, Pennsylvania, United States