Tolerance and Development of Healthy, Term Infants

Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00465764

Enrollment

115

Registered

2007-04-25

Start date

2007-04-30

Completion date

2008-06-30

Last updated

2009-04-27

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

Conditions

Healthy

Keywords

healthy infants

Brief summary

To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.

Interventions

OTHERAlternate protein infant formula

Feed as per HCP directions

OTHERStandard infant formula

Feed as per HCP directions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 8 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy term infants; * Age 0-8 days of age; * Exclusively formula fed; * No use of vitamin/mineral supplements.

Exclusion criteria

* Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Design outcomes

Primary

Measure	Time frame
Mean rank stool consistency at 14 days of age	14 days of age

Secondary

Measure	Time frame
Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding	14 days

Countries

United States

Outcome results

None listed

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