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临床试验/NCT03276247
NCT03276247已完成不适用

Ethnic and Genetic Factors of Iron Status in Women of Reproductive Age

Victor Gordeuk1 个研究点 分布在 1 个国家目标入组 22,042 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22,042
试验地点
1
主要终点
Elevated serum ferritin

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Age >44 years
  • Self-described ethnicity other in than inclusion criterion 2.

结局指标

主要结局

Elevated serum ferritin

时间窗: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

Serum ferritin \>300 ug/L

Elevated serum ferritin and transferrin saturation

时间窗: 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%

Iron deficiency

时间窗: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

Serum ferritin \<15ug/L

次要结局

未报告次要终点

研究者

发起方
Victor Gordeuk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Victor Gordeuk

Professor of Medicine

University of Illinois at Chicago

研究点 (1)

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