NCT02245321

Strategies to Reduce Iron Deficiency

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: Westat · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2014-09-19
• Last updated: 2023-12-06

Locations

4 sites across 1 country: United States