The purpose of the study is to test a food supplement to: * Show that the food supplement is well tolerated and safe to feed to infants; * Find out how often parents/caregivers feed their infants the food supplement; * Find out how parents/caregivers usually add the food supplement to infants' regular solid or liquid food; and * Learn what aspects of the food supplement are more or less attractive to infants and to parents/caregivers.
The study involves parents/caregivers of infants, ≥ 5 months but \< 11 months of age. Parents who enrolled their infants complete a 1-month blinded placebo run-in period, followed by randomization to placebo or the food supplement. During the intervention period, infants randomized to the food supplement are fed a once daily, individual packet of the food supplement mixed into liquid (e.g., breast milk, infant formula) or solid (e.g., applesauce, pureed carrots) foods being fed to the infant. The food supplement is a blend of 16 common allergenic proteins (\[oat, milk, egg, sesame, wheat\] \[almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut\] \[cod, shrimp, salmon\]) combined with 400 IU of Vitamin D3. Parents complete a daily diary about any reactions or symptoms within 2 hours of ingesting the food supplement. Infants randomized to the placebo are also fed a once daily individual packet of the placebo mixed into liquid or solid foods being fed to the infant. Parents also complete a daily diary about any reactions or symptoms within 2 hours of ingesting the placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
705
A powder blend of 16 common allergenic proteins (\[oat, milk, egg, sesame, wheat\] \[almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut\] \[cod, shrimp, salmon\]) combined with 400 IU of Vitamin D3
Jane L Holl
Chicago, Illinois, United States
Allergic-type reaction
difference between the proportion of infants with allergic-type reaction within 2 hours of ingestion in the food supplement versus placebo arm
Time frame: 1month
Symptom
difference between the proportion of infants with a symptom within 2 hours of ingestion of the food supplement versus placebo arm
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.