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NCT Number: NCT07530861

Nutritional and Anthropometric Characteristics of Children With Food Allergy

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.

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Key information

Conditions

Food Allergy in Children Behavior Breast Feeding Feeding Behavior Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Necmettin Erbakan University Faculty of Medicine Hospital

Konya, 42080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Mid-Upper Arm Circumference (cm)

    Time frame: 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).

Secondary outcomes

  1. Height (cm)

    Time frame: At enrollment (November 2021 - June 2023)

    Height/length will be measured using a standard stadiometer or infantometer. Children under 2 years of age will be measured in the supine position (recumbent length), while children aged 2 years and older will be measured in a standing position without shoes. Measurements will be recorded in centimeters (cm).

  2. Head Circumference (cm)

    Time frame: At enrollment (November 2021 - June 2023)

    Head circumference will be measured using a non-stretchable measuring tape in children . The tape will be placed above the eyebrows and around the occipital prominence to obtain the maximum circumference. Measurements will be recorded in centimeters (cm).

  3. Body Weight (kg)

    Time frame: At enrollment (November 2021 - June 2023)

    Body weight will be measured using a calibrated digital scale in children. Children under 2 years of age will be weighed without clothing or wearing a clean diaper, while children aged 2 years and older will be weighed wearing light clothing and no shoes. Measurements will be recorded in kilograms (kg).

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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