Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
NCT ID: NCT04389606
Last Updated: 2021-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
311 participants
INTERVENTIONAL
2020-05-12
2021-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Study Formula (SF)
New infant formula for term infants
Study Formula (SF)
New infant formula for term infants fed ad lib
Comparator Formula (CF)
Commercially available infant formula for term infants fed ad lib
Comparator Formula (CF)
Commercially available infant formula for term infants
Study Formula (SF)
New infant formula for term infants fed ad lib
Comparator Formula (CF)
Commercially available infant formula for term infants fed ad lib
Human Milk Reference Group
Human milk
No interventions assigned to this group
Interventions
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Study Formula (SF)
New infant formula for term infants fed ad lib
Comparator Formula (CF)
Commercially available infant formula for term infants fed ad lib
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Weeks
19 Weeks
ALL
Yes
Sponsors
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Paidion Research, Inc.
INDUSTRY
ByHeart
INDUSTRY
Responsible Party
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Principal Investigators
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Devon Kuehn, MD
Role: STUDY_DIRECTOR
ByHeart, Inc.
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Watching Over Mothers and Babies
Tucson, Arizona, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
San Gabriel Women's Health
Arcadia, California, United States
Northern California Research
Sacramento, California, United States
Optum
Colorado Springs, Colorado, United States
Topaz Clinical Research
Apopka, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Avanza Medical Research
Pensacola, Florida, United States
PAS-Research
Tampa, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Southern Clinical Research
Zachary, Louisiana, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, United States
Schear Family Practice
Dayton, Ohio, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States
Institute of Clinical Research
Mentor, Ohio, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Coastal Pediatric Associates
Summerville, South Carolina, United States
HMG Primary Care at Sapling Grove
Bristol, Tennessee, United States
Jackson Clinic North
Jackson, Tennessee, United States
HMG Pediatrics at Kingsport
Kingsport, Tennessee, United States
Houston Clinical Research Associates
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
ACRC Trials Plano Pediatrics
Plano, Texas, United States
Tanner Clinic
Layton, Utah, United States
Countries
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References
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Kuehn D, Zeisel SH, Orenstein DF, German JB, Field CJ, Teerdhala S, Knezevic A, Patil S, Donovan SM, Lonnerdal B. Effects of a Novel High-Quality Protein Infant Formula on Energetic Efficiency and Tolerance: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):521-528. doi: 10.1097/MPG.0000000000003490. Epub 2022 Jun 6.
Other Identifiers
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SS-101-Follow-up
Identifier Type: -
Identifier Source: org_study_id
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