NCT01699386

Brief Summary

Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 1999

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, 1999

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

October 2, 2012

Last Update Submit

October 2, 2012

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (1)

  • Weight

    weight gain during the study period

    14 days of age to 112 days of age

Secondary Outcomes (3)

  • Anthropometric Measurements

    14 days of age to 112 days of age

  • GI Tolerance

    At visits 14 and 28

  • Lab Measurement

    At 112 day visit

Study Arms (2)

Control Study Formula

ACTIVE COMPARATOR

protein hydrolysate formula

Other: Control Study Formula

Experimental Study Formula

EXPERIMENTAL

free-amino acid-based medical food

Other: Experimental Study Formula

Interventions

Control Study FormulaOTHER

feed as lib

Also known as: protein hydrolysate formula, Nutramigen
Control Study Formula
Experimental Study FormulaOTHER

feed as lib

Also known as: free-amino acid-based medical food, EleCare
Experimental Study Formula

Eligibility Criteria

AgeUp to 9 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Singleton, healthy infant
  • Gestational age of 37 to 42 weeks
  • Birth weight of 2500 grams or greater
  • Age between birth and 9 days of age
  • Parents agree to not administer mineral or vitamin supplements during the study period
  • Parents agree to feed study formula exclusively for the duration of the study

You may not qualify if:

  • Maternal, fetal or perinatal history which may have adverse effects on growth
  • Multiple birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

T&W Research

Little Rock, Arkansas, 72211, United States

Location

University of Iowa

Iowa City, Iowa, 52242-1083, United States

Location

Related Publications (1)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

MeSH Terms

Interventions

pregestimil

Study Officials

  • Marlene W Borschel, PhD, RD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 3, 2012

Study Start

April 1, 1999

Primary Completion

December 1, 2000

Study Completion

December 1, 2000

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations

US(2)