NCT00977964|CompletedPhase 3DMC
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Sponsor study identifier
interventional
270
1 country
15
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 15, 2009
Actual (reported)September 16, 2009
Actual (reported)January 2010
Actual (reported)January 2010
Actual (reported)The primary variable is Gastrointestinal tolerance.
1-28 days of age
The secondary variables are additional measures of GI tolerance and parental feedback.
1-28 days of age
ad lib for 1-8 days of age until 28 days of age
ad lib from 1-8 days of age until 28 days of age
Alabama Clinical Therapeutics
Dothan, Alabama, 36305, United States
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
Plantation, Florida, 33324, United States
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710, United States
University of South Florida
Tampa, Florida, 33606, United States
North Georgia Clinical Research
Dalton, Georgia, 30721, United States
Northpoint Pediatrics, LLC
Indianapolis, Indiana, 46038, United States
Medical Associates Clinic, PC
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
Caude T Ashley, MD
Alabama Clinical Therapeutics, LLC
Terri L Ashmeade, MD
USF Department of Pediatrics
Jay Cohen, MD
Discovery Clinical Research, Inc.
Timothy Crum, MD
Rockwood Clinic
270 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2009
First Posted
September 16, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Gastrointestinal Tolerance of Infant Formula
ad lib from 1-8 days of age to 28 days of age
ad lib from 1-8 days of age until 28 days of age
ad lib from 1-8 days of age until 28 days of age
ad lib from 1-8 days of age until 28 days of age
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Dubuque, Iowa, 52001, United States
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, 40004, United States
Pediatric Associates of Mount Carmel, Inc
Cincinnati, Ohio, 45245, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Ohio Pediatric Research Association, Inc.
Huber Heights, Ohio, 45424, United States
Institute of Clinical Research
Mayfield Heights, Ohio, 44124, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305, United States
Rockwood Clinic North - Pediatrics
Spokane, Washington, 99218, United States
Cole Ezeoke, MD
North Georgia Clinical Research, White's Pediatrics
Sharon Groh-Wargo, PhD, RD, LD
MetroHealth Medical Center
James Guerrieri, MD
Institute of Clinical Research, LLC
James Hedrick, MD
Kentucky Pediatric Research
Jeffrey Hirschfield, MD
SCORE Physician Alliance, LLC
Kevin Mullen, MD
Medical Associates Clinic, PC
Chris Peltier, MD
Pediatric Associates of Mount Carmel, Inc.
Martin J Schear, MD
Dayton Clinical Research
Julie Shepard, MD
Ohio Pediatric Research Association
William Stepp, MD
Sarah Cannon Research Institute, LLC
L Louise Tetrick, MD
Northpoint Pediatrics
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
November 25, 2010
Record last verified: 2010-11
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Source: ClinicalTrials.gov.
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