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临床试验/CTRI/2025/09/095330
CTRI/2025/09/095330尚未招募不适用

Relationship between iron profile and structural alterations in red blood cells using quantitative phase imaging in individual with anemia

Manipal College Of Health Professions1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Variations in morphology of RBC such as volume, surface area, membrane fluctuation in percentage

研究概览

简要总结

Anemia is a widespread health condition defined by reduced red blood cell (RBC) count or low hemoglobin (Hb) concentration, impairing oxygen delivery to tissues and organs. As per the World Health Organization (WHO), it is diagnosed when Hb levels fall below 12 g/dL in females and 13 g/dL in males. Common symptoms include fatigue, dizziness, weakness, headaches, and shortness of breath. Anemia is classified into microcytic, normocytic, and macrocytic types based on mean corpuscular volume (MCV). Diagnosis typically involves measuring Hb, hematocrit, and RBC indices such as MCV, mean cell hemoglobin concentration (MCHC), and reticulocyte count. Additional tests like peripheral blood smear (PBS) and hemoglobin electrophoresis help determine the underlying cause. However, conventional diagnostic methods often lack the ability to capture high-resolution, single-cell-level data, limiting their sensitivity to subtle RBC abnormalities. Assessing RBC structural and biochemical features provides deeper insights into anemia’s pathophysiology, enabling early detection, accurate classification, and improved clinical management. Against this background, the present prospective cross-sectional study aims to assess the relationship between iron levels and structural alteration of red blood cells using Quantitative phase Imaging in 24 individuals aged 20–30 years, including 12 anemic cases and 12 controls. Participants will be voluntarily recruited from individuals visiting Kasturba Hospital for routine health checkups, based on specified inclusion and exclusion criteria and after obtaining informed consent. Data will be statistically analyzed using Jamovi software, applying descriptive statistics (mean, median, standard deviation) and Pearson correlation. This study will enable identifying variations in structural alterations in red blood cells linked to anemia, while also investigating the fluctuation in iron level impact the structure and function of hemoglobin and enhancing the understanding of the biochemical connection between iron status and anemia.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Group 1: Diagnosed with anemia (hemoglobin concentration from 6g/dL to 10g/dL) Age: 20-30 years.
  • All genders are included.
  • Participants with request for complete blood count and Iron profile.
  • Group 2: Individuals without anemia (hemoglobin concentration from 12g/dL to 15g/dL) Age: 20-30 years All genders are included Participants with request for complete blood count and Iron profile.

排除标准

  • Anemia caused by acute blood loss (eg: trauma, surgery).
  • History of blood transfusions in the past 3 months.
  • Participants are currently on medications/supplementation.

结局指标

主要结局

Variations in morphology of RBC such as volume, surface area, membrane fluctuation in percentage

时间窗: At baseline

Iron in mg/dL

时间窗: At baseline

Ferritin in ng/mL

时间窗: At baseline

Correlate morphological variations of RBC with iron profile

时间窗: At baseline

次要结局

未报告次要终点

研究者

发起方
Manipal College Of Health Professions
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Nishmitha Vishwanath Salian

Manipal College Of Health Professions

研究点 (1)

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