NCT01489098

Brief Summary

The purpose of this study is to determine if toddlers and children who were fed breast milk or infant formulas at different levels of protein between 3 and 12 months of age have differences in growth and body composition at 3 and 5 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

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

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

October 1, 2014

Enrollment Period

3.4 years

First QC Date

December 2, 2011

Last Update Submit

March 17, 2015

Conditions

Growth Acceleration

Keywords

Body compositionProtein Metabolism

Outcome Measures

Primary Outcomes (2)

  • Mean weight gain

    3 years

  • Mean weight gain

    5 years

Secondary Outcomes (2)

  • Body composition

    3 years

  • Body composition

    5 years

Study Arms (3)

Breast Fed reference group

3 and 5 year olds from the above group

Infant formula - protein level 1

3 ad 5 year olds from the above group

Infant formula - protein level 2

3 and 5 year olds from the above group

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Toddlers and Children who have previously participated in an infant formula trial where various levels of protein were provided and who are now at the age of 3 and 5 years.

You may qualify if:

  • Previous participation in infant formula controlled protein study
  • Body composition data from 6 month of age available
  • Consent obtained from legal representative
  • Within age parameters specified in protocol around the 3 and 5 year age points

You may not qualify if:

  • Unable to endure testing procedures upon evaluation of the Investigator
  • Outside the age range of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Samuel J Fomon Infant Nutrition Unit Department of Pediatrics, University of Iowa

Iowa City, Iowa, 552242, United States

Location

Department of Pediatrics, University of Oklahoma Health Sciences

Oklahoma City, Oklahoma, 73102, 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
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 9, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 18, 2015

Record last verified: 2014-10

Locations

US(2)