- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530861
Nutritional and Anthropometric Characteristics of Children With Food Allergy
The Relationship Between Nutrition and Allergies in Children Aged 0-6 Years
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Konya, Turkey (Türkiye), 42080
- Necmettin Erbakan University Faculty of Medicine Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children with food allergy (cases)
Children diagnosed with food allergy.
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Healthy children (controls)
Healthy children without chronic diseases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mid-Upper Arm Circumference (cm)
Time Frame: At enrollment (cross-sectional assessment, November 2021 - June 2023)
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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).
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At enrollment (cross-sectional assessment, November 2021 - June 2023)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Height (cm)
Time Frame: At enrollment (November 2021 - June 2023)
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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).
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At enrollment (November 2021 - June 2023)
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Head Circumference (cm)
Time Frame: At enrollment (November 2021 - June 2023)
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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).
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At enrollment (November 2021 - June 2023)
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Body Weight (kg)
Time Frame: At enrollment (November 2021 - June 2023)
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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).
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At enrollment (November 2021 - June 2023)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EY-FOODALL-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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