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OpenTrials
Completed

NCT Number: NCT02481531

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

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.

Completed

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Key information

Conditions

Growth

Age range

10 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Pediatric Associates, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Previously marketed infant formula

Other

Previously marketed formula using a similar protein

Other

Primary outcomes

  1. Body weight measured at each study visit

    Time frame: 12 months

    Measurement collected with a calibrated infant scale

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2015
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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