NCT00916565

Brief Summary

The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

11 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

First Submitted

Initial submission to the registry

June 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

First QC Date

June 5, 2009

Last Update Submit

August 31, 2011

Conditions

Healthy

Keywords

optimize nutritional content of infant formulaInfant

Study Arms (3)

Experimental milk-based infant formula

Control milk-based infant formula

Breastfed Reference Group

Eligibility Criteria

Age10 Days - 18 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

formula-fed and breastfed infants

You may qualify if:

  • days of age
  • weeks gestation
  • birth weight 2500 g or more
  • consuming one source of nutrition

You may not qualify if:

  • metabolic or chronic disease
  • acute infection
  • feeding difficulties
  • consumed complementary foods or donor milk
  • steroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Dr. Claude Ashley

Birmingham, Alabama, 35235, United States

Location

William Johnston, MD

Birmingham, Alabama, 35235, United States

Location

Lori Montgomery, MD

Little Rock, Arkansas, 72205, United States

Location

Edward Zissman, MD

Lake Mary, Florida, 32746, United States

Location

Harold Deulofeut MD

Plantation, Florida, 33324, United States

Location

Harold Deulofeut MD

Tamarac, Florida, 33321, United States

Location

Susan Carlson, Ph.D.

Kansas City, Kansas, 66160, United States

Location

Joseph Leader, MD

Woburn, Massachusetts, 01801, United States

Location

Ann Grandjean, Ed. D

Omaha, Nebraska, 68105, United States

Location

Laurie Harris-Ford, MD

Clarksville, Tennessee, 37043, United States

Location

Beth Nauert, MD

Austin, Texas, 78745, 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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 9, 2009

Study Start

July 1, 2009

Last Updated

September 2, 2011

Record last verified: 2011-08

Locations

US(11)