Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-23 @ 2:34 PM
Study NCT ID:
NCT03667118
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Introduction and Maintenance of Still Eating Protein Blends in Support of Infant Nutritional Goals
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Daily Ingestion of a Multi-Allergen Food Supplement by Infants: Clinical Symptoms, Reactions, and Acceptability - A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
* 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: