Food Allergy in ChildrenNCT07530861
Nutritional and Anthropometric Characteristics of Children With Food Allergy
An observational study of Food Allergy in Children, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy in Children
- How many people
- 185 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 5 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study includes children aged 1 month to 6 years. The case group consists of children diagnosed with food allergy (FA), while the control group consists of healthy children without chronic diseases attending the same hospital. Children with other chronic diseases, genetic disorders, immunodeficiencies, neurological diseases, anatomical malformations, or absorption disorders (e.g., celiac disease) are excluded.
Who may be able to join
- 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
Who cannot join
- Children with other chronic diseases
- Genetic disorders
- Immunodeficiency
- Neurological diseases
- Anatomical malformations
- Absorption disorders (e.g., celiac diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Faculty of Medicine Hospital
Konya, 42080
About this study
Official title: The Relationship Between Nutrition and Allergies in Children Aged 0-6 Years
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.
Read the 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.
- Conditions
- Food Allergy in Children
- Keywords
- Food Allergy, Children, Nutrition, Anthropometry, breastfeeding, complementary foods
- Medical subject headings
- Food Hypersensitivity, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with food allergy (cases) | Children diagnosed with food allergy. | |
| Healthy children (controls) | Healthy children without chronic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-Upper Arm Circumference (cm)
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).
Measured: At enrollment (cross-sectional assessment, November 2021 - June 2023)
Secondary outcomes (3)
Height (cm)
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).
Measured: At enrollment (November 2021 - June 2023)
Head Circumference (cm)
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).
Measured: At enrollment (November 2021 - June 2023)
Body Weight (kg)
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).
Measured: At enrollment (November 2021 - June 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Nov 2021
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530861
- Sponsor's protocol ID
- EY-FOODALL-01
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "This observational study does not plan to share individual participant data."
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Nutrition and Allergies in Children Aged 0-6 Years
- ClinicalTrials.gov ID
- NCT07530861
- Acronym / sponsor ID
- EY-FOODALL-01
- Conditions
- Food Allergy in Children
- Keywords
- Food Allergy, Children, Nutrition, Anthropometry, breastfeeding, complementary foods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with food allergy (cases) | – | –Children diagnosed with food allergy. |
| Healthy children (controls) | – | –Healthy children without chronic diseases |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study includes children aged 1 month to 6 years. The case group consists of children diagnosed with food allergy (FA), while the control group consists of healthy children without chronic diseases attending the same hospital. Children with other chronic diseases, genetic disorders, immunodeficiencies, neurological diseases, anatomical malformations, or absorption disorders (e.g., celiac disease) are excluded.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Children with other chronic diseases
- Genetic disorders
- Immunodeficiency
- Neurological diseases
- Anatomical malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
Height (cm)
Time frame: At enrollment (November 2021 - June 2023)
Head Circumference (cm)
Time frame: At enrollment (November 2021 - June 2023)
Body Weight (kg)
Time frame: At enrollment (November 2021 - June 2023)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Full text of the study on growth and nutrition in children with food allergies.Link provided by the sponsor.
- Individual participant dataSharing planned: No. "This observational study does not plan to share individual participant data."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Children, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid-Upper Arm Circumference (cm) (time frame: At enrollment (cross-sectional assessment, November 2021 - June 2023)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.