Assessment of Growth of Infants Fed a New Formula

Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00937014

Enrollment

180

Registered

2009-07-10

Start date

2010-02-28

Completion date

2013-06-30

Last updated

2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Nutrition

Keywords

infant formula, growth, weight

Brief summary

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.

Interventions

OTHERstandard infant formula

Standard infant formula given during the first 9 months of life, as per standard requirement

OTHERTest formula

Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

11 Days to 17 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy newborn infant * Full-term (\>37 weeks gestation) * Birth weight between \> 2500 and \< 4500 g * Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment * Tolerating a cows milk based formula for at least 3 days * Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information * Informed consent signed (Parent/Legal representative) * Parent/Caregiver has a working freezer * Lives within 45 minutes of a study site

Exclusion criteria

* Congenital illness or malformation that may affect infant feeding and/or normal growth * Suspected or known allergy to cow's milk protein * Significant pre-natal and/or post-natal disease * Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment * Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment * Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements * Infant currently participating in another clinical study * Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Design outcomes

Primary

Measure	Time frame
Mean weight gain	4 months

Secondary

Measure	Time frame
anthropometry, tolerance, morbidity, blood tests	9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026