Tolerance and Development of Healthy, Term Infants

NCT ID: NCT00465764

Last Updated: 2009-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Protein formula

Feed as per HCP direction

Group Type EXPERIMENTAL

Alternate protein infant formula

Intervention Type OTHER

Feed as per HCP directions

Standard infant formula

Feed as per HCP instructions

Group Type ACTIVE_COMPARATOR

Standard infant formula

Intervention Type OTHER

Feed as per HCP directions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alternate protein infant formula

Feed as per HCP directions

Intervention Type OTHER

Standard infant formula

Feed as per HCP directions

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

8 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abbott Nutrition

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marlene W Borschel, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

Site Status

Children's Nutrition Research Center, Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37929831 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AK44

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Formula Tolerance of Term Infants
NCT04915937 COMPLETED NA