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Introduction and Maintenance of Still Eating Protein Blends in Support of Infant Nutritional Goals

NCT03667118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2019-03-13

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Food Supplement

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

Sponsors & Collaborators

Principal Investigators

  • Jane L Holl, MD MPH · Professor of Pediatrics, Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-18
Primary Completion
2017-10-09
Completion
2017-10-09

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03667118 on ClinicalTrials.gov