Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy

June 29, 2023 updated by: University Medical Centre Ljubljana

The goal of this single center retrospective cohort study with observational longitudinal follow up is to compare food - allergic children (egg, milk and peanut allergy) with children in control group (children without any food allergy).

The main question[s] it aims to answer are:

  • If children with food allergy groups will have lower food intake od micronutrients?
  • If growth in children with food allergy is worse as in control group?
  • If they are more malnourished and in the food allergies group is more stunting than in the control group?
  • If children with milk allergy have lower intake of calcium in their diet and lower mineral bone density?

Participants will be asked to do 3 day food diary and to have blood analysed (hemograme, complete blood count, serum iron status, serum protein).

If there is a comparison group: Researchers will compare milk, egg and peanut allergy group to the control group (peers without food allergy) to see if the food allergy affects growth, macronutrient, micronutrient intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design A single center retrospective cohort study with observational longitudinal follow up will be performed. The study will include three intervention groups (milk, egg and peanut allergy) and a control group (children with no food allergy). Patients will be 2 to 12 years old. The patients will be recruited at our University Medical Center Ljubljana, Pediatric hospital Ljubljana, outpatient care of our Department for Allergology, Rheumatology and Clinical Immunology. This study will be conducted according to the guidelines in Declaration of Helsinki and approved by Ethics Committee of Slovenia. Written informed consent will be obtained from all the subject's caregivers. The investigators will follow patients from confirmation of food allergy on and will collect data about their weight (kg) and height (cm) from our information system or patients' doctor (or caregiver). The investigators will collect data prospectively for 3 months from outpatient registry of our clinic. At the day of appointment patients will bring 3-day nutrition diary which was later analyzed by dietitian. The parents will attend an appointment by the dietitian where they will be informed about food diary analysis result and given the advice to enhance nutrition if necessary.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Universitiy Medical center Ljubljana, division for Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with food-allergy were between 2 and 12 years old. All children in intervention group had IgE-mediated food allergy (skin prick test and/or specific IgE combined with an allergy focused history) to milk, egg or peanut.

In control group there were children between 2 and 12 years old, with no food allergy (patients with bee venom or drug allergy).

Description

Inclusion Criteria:

  • IgE-mediated food allergy (skin prick test and/or specific IgE combined with an allergy focused history)

Exclusion Criteria:

  • other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),
  • vegetarian or vegan nutrition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Milk allergy
Children with milk allergy.
Biological: Blood sample analysis
Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.
Radiation: Bone mineral density measurement (DXA)
Analysis of bone mineral density with DXA in patients with milk allegy. Analysis ordered by medical doctor.
Other: Influence of food allergy on growth (intervention groups)
Gathering the data about of body height (cm), weight (kg) BMI (kg/m2) at the diagnosis of food allergy and comparison versus data at the enrollment in the study to asses growth.
Egg Allergy
Children with egg allergy
Biological: Blood sample analysis
Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.
Other: Influence of food allergy on growth (intervention groups)
Gathering the data about of body height (cm), weight (kg) BMI (kg/m2) at the diagnosis of food allergy and comparison versus data at the enrollment in the study to asses growth.
Other: Anthropometrics measurement - at inclusion to the study (all groups).
Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control.
Peanut allergy
Children with peanut allergy
Biological: Blood sample analysis
Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.
Other: Influence of food allergy on growth (intervention groups)
Gathering the data about of body height (cm), weight (kg) BMI (kg/m2) at the diagnosis of food allergy and comparison versus data at the enrollment in the study to asses growth.
Other: Anthropometrics measurement - at inclusion to the study (all groups).
Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control.
Control group
Patients withhout food allergy (bee venom or drug allergy).
Biological: Blood sample analysis
Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.
Other: Anthropometrics measurement - at inclusion to the study (all groups).
Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of food allergy on growth
Time Frame: 6 years
Patients body weight (kg), height (cm) and use WHO growth curves to asses their growth and nutritional status and compare the to control group. Comparison of their measurements against the measurements at the time od diagnosis to asses the influence on growth.
6 years
Influence of food allergy on food intake and nutrient intake
Time Frame: 29 months
Patients caregivers will deliver 3 - day food diary and dietitan will analyse it (energy intake - kcals/KJ, intake of proteins kg/kg of body weight/day, intake of calcium and iron in mg/day and %of fat, %of carbohydrates and % of proteins in their nutrition. It will all be compared to the control group..
29 months
Influence of food allergy on blood sampling analysis
Time Frame: 29 months
Blood sample analysis will be performed and results of intervention groups compared versus control group
29 months
Influence of milk allergy on bone mineral density
Time Frame: 29 months
Data of bone mineral density will be gathered from our patients database and analysed
29 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Director: Tadej Avcin, prof., Head of Department of Clinical Immunology, Rheumatology and Allergology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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