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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05937061
• Other study ID #: 20200133
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),

• vegetarian or vegan nutrition.

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

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.

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.

Locations

Country	Name	City	State
Slovenia	Universitiy Medical center Ljubljana, division for Pediatrics	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Influence of milk allergy on bone mineral density	Data of bone mineral density will be gathered from our patients database and analysed	29 months