Cow's Milk Protein Allergy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Parent or legal guardian of a toddler with a medically diagnosed cow’s milk protein allergy (IgE-mediated, non-IgE-mediated, or unclassified) - Parent or legal guardian of a child aged 12 to 36 months - Willingness and ability to complete a 3-day dietary record and fully answer the questionnaire - Voluntary consent to participate in the study
Exclusion criteria
Exclusion criteria: - Age of the parent or legal guardian under 18 years - Parents or legal guardians of children who are predominantly fed enterally or parenterally - Parents or legal guardians of children with chronic or acute conditions that require a special therapeutic diet independent of the cow’s milk protein allergy (e.g., metabolic disorders, celiac disease, cystic fibrosis) - Insufficient language skills (German or English) to fully understand study information and protocol instructions - Missing or incomplete consent from the parent or legal guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Median actual daily nutrient intake for the following macro- and micronutrients: energy, protein, vitamin D, vitamin A, folic acid, vitamin B2, vitamin B12, calcium, iron, zinc, and iodine. 2. Percentage of children whose daily intake is < 80% of the age-specific reference value. These parameters are assessed once using a 3-day dietary record. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in nutrient intake between groups (therapeutic formula vs. no therapeutic formula), calculated using medians and the p-value from the Mann–Whitney U test. 2. Association between type of milk substitute and the presence of current CMPA symptoms and additional allergies (Spearman correlation coefficient and corresponding p-value). 3. Frequency of use of specific milk substitute products, expressed as percentages. 4. Importance of various decision-making factors for choosing milk substitute products, expressed as the percentage of parents who rate each factor as important. | — |
Countries
Germany
Contacts
Universitätsklinikum Schleswig-Holstein