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NCT Number: NCT05937061

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

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.

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Key information

Conditions

Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitiy Medical center Ljubljana, division for Pediatrics

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Blood Sample Analysis

Biological

Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.

Anthropometrics measurement - at inclusion to the study (all groups).

Other

Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control.

Bone mineral density measurement (DXA)

Radiation

Analysis of bone mineral density with DXA in patients with milk allegy. Analysis ordered by medical doctor.

Influence of food allergy on growth (intervention groups)

Other

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.

Primary outcomes

  1. 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.

  2. 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..

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

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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