NCT00465764

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_2 healthy

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 27, 2009

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

April 23, 2007

Last Update Submit

April 24, 2009

Conditions

Healthy

Keywords

healthy infants

Outcome Measures

Primary Outcomes (1)

  • Mean rank stool consistency at 14 days of age

    14 days of age

Secondary Outcomes (1)

  • Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding

    14 days

Study Arms (2)

Protein formula

EXPERIMENTAL

Feed as per HCP direction

Other: Alternate protein infant formula

Standard infant formula

ACTIVE COMPARATOR

Feed as per HCP instructions

Other: Standard infant formula

Interventions

Alternate protein infant formulaOTHER

Feed as per HCP directions

Protein formula
Standard infant formulaOTHER

Feed as per HCP directions

Standard infant formula

Eligibility Criteria

Age1 Day - 8 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68505, United States

Location

Children's Nutrition Research Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

    PMID: 37929831DERIVED

Study Officials

  • Marlene W Borschel, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

April 27, 2009

Record last verified: 2008-06

Locations

US(2)