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临床试验/NCT07530861
NCT07530861已完成不适用

The Relationship Between Nutrition and Allergies in Children Aged 0-6 Years

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2021年11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
185
试验地点
1
主要终点
Mid-Upper Arm Circumference (cm)

研究概览

简要总结

This observational study evaluates the nutritional habits and anthropometric measurements of children aged 0-6 years with food allergy (FA). Children with FA (case group) and healthy children (control group) were included. Written informed consent was obtained from all participants' parents, and the study was conducted in accordance with the Declaration of Helsinki. Data collected included children's nutritional history, family sociodemographic information, anthropometric measurements, and laboratory parameters. The study compares case and control groups to provide insights into the growth and nutritional profiles of children with food allergy.

详细描述

This observational case-control study investigates the nutritional habits and anthropometric characteristics of children aged 0-6 years with food allergy (FA). The study included children diagnosed with FA (case group) and healthy children of the same age and sex (control group).

Sociodemographic data were collected from families, including parental education, occupation, income, and family history of allergies. Nutritional information included breastfeeding history, age at introduction of complementary foods, and types of complementary foods. Anthropometric measurements recorded were height, weight, body mass index, upper mid-arm circumference, and head circumference. Laboratory parameters, such as complete blood count, total and food-specific IgE, albumin, and tryptase, were also recorded.

Data collection was conducted by trained personnel: nutritional and sociodemographic data via face-to-face interviews with parents, and anthropometric measurements by a dietician using standard methods. FA diagnosis was confirmed based on clinical history, skin prick tests, and/or serum-specific IgE tests.

The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all parents, and the research protocol was approved by the Necmettin Erbakan University Meram Faculty of Medicine Non-Interventional Clinical Research Ethics Committee (protocol number: 04.10.2019, 2019/2011).

This study provides information on the growth, nutritional habits, and health profiles of children with food allergy compared to healthy peers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Month 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1 month to 6 years
  • Case group: children diagnosed with food allergy (FA)
  • Control group: healthy children attending the general pediatrics outpatient clinic of the same hospital

排除标准

  • Children with other chronic diseases
  • Genetic disorders
  • Immunodeficiency
  • Neurological diseases
  • Anatomical malformations
  • Absorption disorders (e.g., celiac diseases.

研究组 & 干预措施

Children with food allergy (cases)

Children diagnosed with food allergy.

Healthy children (controls)

Healthy children without chronic diseases

结局指标

主要结局

Mid-Upper Arm Circumference (cm)

时间窗: At enrollment (cross-sectional assessment, November 2021 - June 2023)

Mid-upper arm circumference (MUAC) will be measured as an indicator of nutritional status. The measurement will be taken at the midpoint between the acromion and olecranon processes of the non-dominant arm using a non-stretchable measuring tape. All measurements will be recorded in centimeters (cm).

次要结局

  • Height (cm)(At enrollment (November 2021 - June 2023))
  • Head Circumference (cm)(At enrollment (November 2021 - June 2023))
  • Body Weight (kg)(At enrollment (November 2021 - June 2023))

研究者

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

Elif Yıldırım

Assistant Professor

Necmettin Erbakan University

研究点 (1)

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