Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-05 @ 2:47 AM
Study NCT ID:
NCT05937061
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2023-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
Sponsor:
University Medical Centre Ljubljana
Organization:
Study Overview
Official Title:
Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: