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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

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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


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).



Information from the National Library of Medicine

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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
Show Show 22 study locations
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
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Study Director: Carol Lynn Berseth, M.D. Mead Johnson and Company
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT02132663    
Other Study ID Numbers: 3386-1
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015