Iron Depletion and Replacement in Blood Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation
研究概览
简要总结
The purpose of this study is to determine (1) the role of ferritin testing to screen for iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers to routinely distribute oral iron replacement therapy to donors.
详细描述
This prospective study will be conducted under IRB approval at Memorial Blood Centers. Approximately 1000 donors will be enrolled over a two-year period.
Participant Recruitment Donors presenting to donate whole blood at MBC who have a Hb value between 12.5-13.5 (males) or 12.0-13.0 (females) will be asked to participate. Written informed consent will be obtained from each participant.
STUDY PROCEDURES MBC will be responsible for donor consenting, specimen collection and testing, donor deferral, donor-follow-up, and record keeping. Before any study participation, donors who meet the inclusion criteria will be required to sign and date an informed consent. All participants will receive a study information sheet and be asked screening questions and donor information.
An EDTA and red top tube will be taken from the diversion pouch of each participant during their donation, or obtained from samples already drawn for donor screening. The EDTA sample and red top tube will be used to determine baseline CBC and ferritin levels, respectively.
Female participants who have a Hb of 12.0-12.4 will not be allowed to donate per FDA regulations, but will be asked to have an EDTA and red top tube drawn to determine baseline CBC and ferritin levels, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fingerstick Hb value of 12.5-13.5 (males) or 12.0-13.0 (females)
- •Meets all other blood donor inclusion criteria
- •=>18 years of age
排除标准
- •History or family history of hemochromatosis, colon cancer, intestinal polyps, or chronic gastrointestinal disease
- •Currently taking iron in a form other than a multivitamin
- •Currently on a chronic therapeutic use of NSAIDS or anticoagulants
结局指标
主要结局
Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation
时间窗: Two years
Subject self reported habits for taking iron supplement or iron rich diet and severity of gastrointestinal complaints (minimal-1 to severe-5). GI complaints were not separated by type for analysis.
次要结局
- Number of Participants With Improved Ferritin Levels on Subsequent Visit(Two years)