Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 702
- 试验地点
- 8
- 主要终点
- Hemoglobin (HgB)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Hemoglobin (HgB)
时间窗: Change from baseline in HgB over 2 years
a protein responsible for transporting oxygen in the blood
次要结局
- Ferritin(Change from baseline in ferritin over 2 years)
- Soluble transferrin receptor (sTfR)(Change from baseline in sTfR over 2 years)
- Laboratory Hematology results(Change from baseline in Laboratory hematology results over 2 years.)