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Nutrient Intake and Parental Decision-Making in Toddlers (12–36 Months) with Cow's Milk Protein Allergy in Germany: A Cross-Sectional Analysis

Nutrient Intake and Parental Decision-Making in Toddlers (12–36 Months) with Cow's Milk Protein Allergy in Germany: A Cross-Sectional Analysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038571
Enrollment
30
Registered
2026-02-02
Start date
2026-02-25
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Protein Allergy

Interventions

Group 1: Parents of toddlers (12–36 months old) with cow’s milk protein allergy complete a one-time questionnaire on dietary habits, allergy symptoms, and product preferences. In addition, the parents

Sponsors

Universität zu Lübeck
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactMartin Smollich

Universitätsklinikum Schleswig-Holstein

martin.smollich@uksh.de+ 49 (0) 451 3101-8401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026