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

NCT05937061 | Completed

• 1 other identifier: 20200133
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (4)

• Influence of food allergy on growth

  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

  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

  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

  Data of bone mineral density will be gathered from our patients database and analysed

  29 months

Study Arms (4)

Milk allergy

Children with milk allergy.

Biological: Blood sample analysis; Radiation: Bone mineral density measurement (DXA); Other: Influence of food allergy on growth (intervention groups)

Egg Allergy

Children with egg allergy

Biological: Blood sample analysis; Other: Anthropometrics measurement - at inclusion to the study (all groups).; Other: Influence of food allergy on growth (intervention groups)

Peanut allergy

Children with peanut allergy

Biological: Blood sample analysis; Other: Anthropometrics measurement - at inclusion to the study (all groups).; Other: Influence of food allergy on growth (intervention groups)

Control group

Patients withhout food allergy (bee venom or drug allergy).

Biological: Blood sample analysis; Other: Anthropometrics measurement - at inclusion to the study (all groups).

Interventions

Blood sample analysis BIOLOGICAL

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

Control group; Egg Allergy; Milk allergy; Peanut allergy

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.

Control group; Egg Allergy; Peanut allergy

Bone mineral density measurement (DXA) RADIATION

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

Milk allergy

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.

Egg Allergy; Milk allergy; Peanut allergy

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Universitiy Medical center Ljubljana, division for Pediatrics

Ljubljana, 1000, Slovenia

Location

Related Publications (6)

• Berni Canani R, Leone L, D'Auria E, Riva E, Nocerino R, Ruotolo S, Terrin G, Cosenza L, Di Costanzo M, Passariello A, Coruzzo A, Agostoni C, Giovannini M, Troncone R. The effects of dietary counseling on children with food allergy: a prospective, multicenter intervention study. J Acad Nutr Diet. 2014 Sep;114(9):1432-9. doi: 10.1016/j.jand.2014.03.018. Epub 2014 Jun 3.

  PMID: 24933388 BACKGROUND

• Beck C, Koplin J, Dharmage S, Wake M, Gurrin L, McWilliam V, Tang M, Sun C, Foskey R, Allen KJ; HealthNuts Investigators. Persistent Food Allergy and Food Allergy Coexistent with Eczema Is Associated with Reduced Growth in the First 4 Years of Life. J Allergy Clin Immunol Pract. 2016 Mar-Apr;4(2):248-56.e3. doi: 10.1016/j.jaip.2015.08.009. Epub 2015 Oct 2.

  PMID: 26441150 BACKGROUND

• Meyer R, De Koker C, Dziubak R, Godwin H, Dominguez-Ortega G, Chebar Lozinsky A, Skrapac AK, Gholmie Y, Reeve K, Shah N. The impact of the elimination diet on growth and nutrient intake in children with food protein induced gastrointestinal allergies. Clin Transl Allergy. 2016 Jul 14;6:25. doi: 10.1186/s13601-016-0115-x. eCollection 2016.

  PMID: 27418957 BACKGROUND

• Mailhot G, Perrone V, Alos N, Dubois J, Delvin E, Paradis L, Des Roches A. Cow's Milk Allergy and Bone Mineral Density in Prepubertal Children. Pediatrics. 2016 May;137(5):e20151742. doi: 10.1542/peds.2015-1742.

  PMID: 27244780 BACKGROUND

• Robbins KA, Wood RA, Keet CA. Milk allergy is associated with decreased growth in US children. J Allergy Clin Immunol. 2014 Dec;134(6):1466-1468.e6. doi: 10.1016/j.jaci.2014.08.037. Epub 2014 Oct 11. No abstract available.

  PMID: 25312758 BACKGROUND

• Kim J, Kwon J, Noh G, Lee SS. The effects of elimination diet on nutritional status in subjects with atopic dermatitis. Nutr Res Pract. 2013 Dec;7(6):488-94. doi: 10.4162/nrp.2013.7.6.488. Epub 2013 Nov 29.

  PMID: 24353835 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for analysis

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Tadej Avcin, prof.

  Head of Department of Clinical Immunology, Rheumatology and Allergology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: July 10, 2023
• Study Start: May 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)