The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
Study Purpose
Cow's milk allergy (CMA) is the most common Food Allergy (FA) in children, and the essential strategy in prevention is avoiding the allergens that may cause potentially life-threatening reactions. The primary developmental task of early childhood is the creation of healthy eating habits. The diagnosis of FA in this period can lead to permanent changes in the life of the child and her family. In early childhood, parents are often responsible for all aspects of FA management because children are too young to understand the complexity of avoiding allergens. Children often do not have the skills to implement FA management. Parents are advised to follow a special weaning diet, avoiding any type of cow's milk, usually at least 1 year old. However, depending on the clinical improvement, it can be recommended to continue this exclusion diet for much longer. Thus, many children have to exclude a large group of food from their diets, which is critical for their growth, development, and eating habits. This may raise mealtime behavioral anxiety in a child with a FA. Eating behavioral anxieties are also very common in healthy, typically developing children. Even 25% to 45% of normally developing children's parents report concerns about their child's nutritional and mealtime behaviors, including the destructive child behaviors (eg., refusal of foods, food selectivity, and getting off the table). In children with food allergies, monitoring long-term growth after the diet is another important issue. Growth problems were reported in 21% of children with FA diagnosed with malnutrition. Most studies focused on the effect of changes in eating behavior on growth during an elimination diet or in short term intervals. Its long-term effects have only been analyzed in a few studies. We aimed to investigate the eating behaviors, nutritional status, and growth of young children (ages of 2 to 6) who had a strict diet due to CMA in early childhood (ages of 0-2).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Unknown |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 2 Years - 6 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04576845 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Saglik Bilimleri Universitesi |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | Turkey |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Nutrient Deficiency, Eating Behavior, Cow Milk Allergy, Growth Disorders |
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