Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Influence of food allergy on blood sampling analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IgE-mediated food allergy (skin prick test and/or specific IgE combined with an allergy focused history)
排除标准
- •other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),
- •vegetarian or vegan nutrition.
结局指标
主要结局
Influence of food allergy on blood sampling analysis
时间窗: 29 months
Blood sample analysis will be performed and results of intervention groups compared versus control group
Influence of food allergy on growth
时间窗: 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.
Influence of food allergy on food intake and nutrient intake
时间窗: 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..
Influence of milk allergy on bone mineral density
时间窗: 29 months
Data of bone mineral density will be gathered from our patients database and analysed
次要结局
未报告次要终点