A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,521
- 试验地点
- 1
- 主要终点
- Prevalence of iron deficiency anemia (ID stage III)
研究概览
简要总结
The purpose of this study is to assess the iron status and to confirm the usability of the non-invasive ZnPP measurement for screening the different stages of iron deficiency defined by standard measurements from blood.
详细描述
Brief description: The purpose of this study is to assess the iron status and to confirm the usability of the non-invasive ZnPP measurement for screening the different stages of iron deficiency defined by standard measurements from blood.
Detailed Description:
The primary objective of this study is to assess the iron status and the prevalence of the different stages of iron deficiency measured and defined by the standard blood iron measurements and by the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip.
The secondary objective is to compare and to assess the usability of the non-invasive ZnPP measurement versus other standard iron status measurements from blood in distinguishing the different stages of iron deficiency.
Subjects will be enrolled into the study after signing an assent form in addition to having parental informed consent signed. Total study duration is 1 day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
no masking required. assessments are both done on same subjects.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 6 - 11 years old
- •Having obtained his/her informed assent.
- •Informed consent signed by one parent or legal authorized representative if applicable.
排除标准
- •Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
- •Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.
- •Any disease of the lip and mouth that does not allow performing the lip measurement.
- •Diagnosis of any blood disorders affecting red blood cells ( aplastic anemia, autoimmune hemolytic anemia, thalassemia)
- •Diagnosis of any blood disorders affecting white blood cells (lymphoma, multiple myeloma, myeloplastic syndrome)
- •Diagnosis of any blood disorders affecting platelets ( idiopathic thrombocytopenic purpura, primary thrombocythemia)
- •Diagnosis of blood plasma ( hemophilia, von Willebrand disease)
- •Diagnosis of acute or chronic inflammatory disease (respiratory tract, digestive tract -bowel, liver, and any kidney disease)
- •Diagnosis of any neoplastic disease
结局指标
主要结局
Prevalence of iron deficiency anemia (ID stage III)
时间窗: From Screening till study completion or up to 7 days, whichever comes first
Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip
Prevalence of Anemia but no ID
时间窗: From Screening till study completion or up to 7 days, whichever comes first
Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip
Prevalence of Iron deficient erythropoiesis (ID stage II)
时间窗: From Screening till study completion or up to 7 days, whichever comes first
Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip
Prevalence of Iron deficiency (ID stage I)
时间窗: From Screening till study completion or up to 7 days, whichever comes first
Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip
Prevalence of Iron deficiency using total body iron stores (TBIS)
时间窗: From Screening till study completion or up to 7 days, whichever comes first
Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip
Prevalence of iron deficiency using the non-invasive zinc protoporphyrin (ZnPP) measurements
时间窗: From Screening till study completion or up to 7 days, whichever comes first
Iron status / prevalence of different stages of iron deficiency (ID) measured and defined by the standard blood iron measurements and the non-invasive measurement of red blood cell Zinc Protoporphyrin fluorescence in the microcirculation of the lower lip
次要结局
- Comparison the non-invasive ZnPP with other standard blood iron status measurements(From Screening till study completion or up to 7 days, whichever comes first)