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The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants

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ClinicalTrials.gov Identifier: NCT02132663
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition

Brief Summary:
This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.

Condition or disease Intervention/treatment Phase
Growth of Term Infants Other: Control: Marketed routine infant formula Other: An investigational infant formula containing an alternate source of DHA Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
Study Start Date : May 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Infant formula containing an alternate source of DHA Other: An investigational infant formula containing an alternate source of DHA
Active Comparator: Marketed routine infant formula Other: Control: Marketed routine infant formula



Primary Outcome Measures :
  1. Body weight measured at each study visit [ Time Frame: 3.5 Months ]

Secondary Outcome Measures :
  1. Recall of infant formula intake at each study visit [ Time Frame: 3.5 months ]
  2. Body length measured at each study visit [ Time Frame: 3.5 months ]
  3. Recall of stool consistency measured at each study visit [ Time Frame: 3.5 months ]
  4. Medically-confirmed adverse events collected throughout the study period [ Time Frame: 3.5 months ]
  5. Head circumference measured at each study visit [ Time Frame: 3.5 months ]
  6. Recall of gastrointestinal tolerance measured at each study visit [ Time Frame: 3.5 months ]
  7. Blood Collection [ Time Frame: Once at 120 days of age ]
    Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA).



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton, 10-14 days of age at randomization
  • Term infant with birth weight of a minimum of 2500 grams
  • Solely formula fed
  • Signed Informed Consent and Protected Health Information

Exclusion Criteria:

  • History of underlying metabolic or chronic disease or immunocompromised
  • Feeding difficulties or formula intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132663


Locations
United States, Alabama
Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35205
Greenvale Pediatrics - Hoover
Birmingham, Alabama, United States, 35244
Southeastern Pediatric Association
Dothan, Alabama, United States, 36305
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, United States, 35126
United States, Arkansas
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States, 72703
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States, 72401
United States, Connecticut
Norwich Pediatric Group, PC
Norwich, Connecticut, United States, 06360
United States, Florida
Children's Research, LLC
Altamonte Springs, Florida, United States, 32701
Physician Care Clinical Research
Sarasota, Florida, United States, 34239
United States, Indiana
Deaconess Clinical Research
Evansville, Indiana, United States, 47725
United States, Kentucky
Owensboro Pediatrics
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
Woburn Pediatic Associates
Woburn, Massachusetts, United States, 01801
United States, North Carolina
Cary Pediatric Center
Cary, North Carolina, United States, 27511
Capital Pediatrics & Adolescent Center
Raleigh, North Carolina, United States, 27609
United States, Ohio
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, United States, 45245
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States, 45014
UHMP Comprehensive Pediatrics
Westlake, Ohio, United States, 44145
United States, South Carolina
Coastal Pediatric Research
Charleston, South Carolina, United States, 29414
United States, Tennessee
The Jackson Clinic - North Jackson
Jackson, Tennessee, United States, 38305
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin Diagnostic Clinic
Austin, Texas, United States, 78745
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Carol Lynn Berseth, M.D. Mead Johnson and Company

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT02132663     History of Changes
Other Study ID Numbers: 3386-1
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015