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Growth and Tolerance of Cow's Milk-Based Infant Formulas

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ClinicalTrials.gov Identifier: NCT02481531
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition

Study Description
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Brief Summary:
This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.

Condition or disease Intervention/treatment Phase
Growth Other: Previously marketed infant formula Other: Previously marketed formula using a similar protein Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Growth and Tolerance of Cow's Milk-Based Infant Formulas
Study Start Date : July 2015
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Previously marketed infant formula
Cow's milk-based infant formula
 Other: Previously marketed infant formula
Experimental: Previously marketed formula using a similar protein
Cow's milk-based infant formula
 Other: Previously marketed formula using a similar protein


Outcome Measures
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Primary Outcome Measures :
  1. Body weight measured at each study visit [ Time Frame: 12 months ]
    Measurement collected with a calibrated infant scale


Secondary Outcome Measures :
  1. Body length measured at each study visit [ Time Frame: 12 months ]
    Measurement collected with a standardized length board

  2. Head circumference measured at each study visit [ Time Frame: 12 months ]
    Measurement collected with a standardized measuring tape

  3. Parental recall of study formula intake at each study visit [ Time Frame: 12 months ]
  4. Parental recall of stool consistency measured at each study visit [ Time Frame: 12 months ]
  5. Blood Collection [ Time Frame: Once at 12 months ]
    Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein

  6. Medically-confirmed adverse events collected throughout the study period [ Time Frame: 12 months ]

Eligibility Criteria
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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:

  • Anemia at time of birth
  • Current use of iron or iron-containing supplements
  • History of underlying metabolic or chronic disease or immunocompromised
  • Feeding difficulties or formula intolerance
Contacts and Locations
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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): NCT02481531


Locations
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Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
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Study Director: Steven Wu, M.D. Mead Johnson and Company
More Information
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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT02481531    
Other Study ID Numbers: 3387-1
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017