Iron Status in Women of Reproductive Age Reproductive Age
2017年9月7日 更新者：Victor Gordeuk
Ethnic and Genetic Factors of Iron Status in Women of Reproductive Age
Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in the United States and Canada using de-identified data from the HEIRS study.
研究概览
详细说明
HEIRS included a cross-sectional screening study of 101,168 patients, 25 years of age or older, in the primary care setting.
Participants were recruited from four centers in the U.S .and
one in Canada from February 2001 to February 2003.
We will evaluate results for women aged 25-44 years of age who are self-reported as Asian, Black, Hispanic or White.
The lower detection limit for the serum ferritin (SF) assay in the HEIRS study was 15 μg/L and therefore the definition of iron deficiency will be SF concentration ≤ 15 μg/L.
Elevated SF concentrations, possibly indicative of elevated iron stores, will be classified by two definitions: 1) SF concentration > 300 μg/L and 2) SF >200 μg/L in combination with TSAT >45%.
Proportions will be compared by Pearson's chi-square.
Logistic regression models will be used to identify independent associations with measures of iron deficiency and elevated iron stores.
研究类型
观察性的
注册 (实际的)
22042
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60612
- University of Illinois at Chicago
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 44年 (成人)
接受健康志愿者
不适用
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Primary care women included in the HEIRS study.
描述
Inclusion Criteria:
- primary care women included in the HEIRS study with in the age range of this study
- Self designation as Asian American, African American, Hispanic American or White.
Exclusion Criteria:
- Age >44 years
- Self-described ethnicity other in than inclusion criterion 2.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Asian American non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and non-pregnant/non-breastfeeding.
|
观察
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|
African American non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and non-pregnant/non-breastfeeding.
|
观察
|
|
Hispanic American non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and non-pregnant/non-breastfeeding.
|
观察
|
|
White non-pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as white and non-pregnant/non-breastfeeding.
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观察
|
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Asian American pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and pregnant or breastfeeding.
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观察
|
|
African American pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and pregnant or breastfeeding.
|
观察
|
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Hispanic American pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and pregnant or breastfeeding.
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观察
|
|
White pregnant
Women 25 to 44 years of age recruited in a primary care setting and self reported as White and pregnant or breastfeeding.
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观察
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Elevated serum ferritin
大体时间：One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
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Serum ferritin >300 ug/L
|
One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
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|
Elevated serum ferritin and transferrin saturation
大体时间：One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
|
Serum ferritin >200 ug/L and transferrin saturation >45%
|
One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
|
|
Iron deficiency
大体时间：One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
|
Serum ferritin <15ug/L
|
One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Victor R Gordeuk, MD、University of Illinois at Chicago
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年1月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年8月1日
研究注册日期
首次提交
2017年9月1日
首先提交符合 QC 标准的
2017年9月7日
首次发布 (实际的)
2017年9月8日
研究记录更新
最后更新发布 (实际的)
2017年9月8日
上次提交的符合 QC 标准的更新
2017年9月7日
最后验证
2017年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.