Skip to main content
OpenTrials
Completed

NCT Number: NCT02132663

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth of Term Infants

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

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

Treatment and study plan

Control: Marketed routine infant formula

Other

An investigational infant formula containing an alternate source of DHA

Other

Primary outcomes

  1. Body weight measured at each study visit

    Time frame: 3.5 Months

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 7, 2014
Registry last updated
May 1, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.