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临床试验/NCT06283342
NCT06283342已完成不适用

The Role of Prophylactic Iron Use and Nutrition in Preventing Iron Deficiency in Infancy

Konya Meram State Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018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
入组人数
2
试验地点
1
主要终点
Ferritine level

研究概览

简要总结

This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy.

详细描述

Iron plays an important role in oxidation and reduction reactions, which have a very important place in the continuation of life. Iron plays an essential role in these reactions because it can easily gain and lose electrons in redox reactions. Iron is mostly found in the heme molecule in organisms. However, iron has structural and functional importance for many enzymes and proteins other than heme. Iron deficiency (ID) is the most common nutritional deficiency in children worldwide. ID is more common in socio-economically developing geographies. However, it is still an important problem in developed countries. A plasma ferritin level below 12 mg/L is defined as ID, which is often used synonymously with iron deficiency anemia (IDA). However, ID develops before anemia occurs. Weakness, fatigue, tiring quickly, insomnia, and regression in neuro-cognitive functions may occur in ID that precedes the signs of anemia. With the development of anemia, the clinical diagnosis of IDA is fully revealed.

In ID that occurs in infancy, psychomotor development is adversely affected, and the development of cognitive functions slows down or even stops. Immune system functions regress. Although iron treatment can reverse these negative effects, some effects are permanent. Therefore, prevention of ID is more important than treatment. In addition, it is easier and cheaper to prevent ID and IDA than to treat them. It is a health policy to recommend iron prophylaxis to children aged 4-12 months in the Republic of Turkey.

Adding iron-rich foods to the diet, adequate breast milk intake, and prophylaxis with iron preparations can be used to prevent ID and IDA. However, there are different data in the literature on the use of prophylactic iron preparations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 6-24 months and admitted to the general pediatrics outpatient clinic

排除标准

  • Chronic disease
  • Blood transfusion history,
  • Thalassemia carrier status
  • Clinical diagnosis of infection or elevated C-reactive protein (CRP)
  • Patients who received iron deficiency or iron deficiency anemia treatment
  • Those who were born prematurely
  • Patients with low birth weight

结局指标

主要结局

Ferritine level

时间窗: day 1

Ferritin level below 12 mg/L was considered iron deficiency.

次要结局

  • Iron-sufficient supplementary food intake rate of babies(15 days)
  • Breast milk usage rate(15 days)
  • Prophylactic iron use rate(15 days)
  • Hemoglobin level(day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alpaslan Şahin

Principal Investigator

Konya Meram State Hospital

研究点 (1)

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