NCT01583673

Brief Summary

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

17 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

April 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 21, 2015

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

April 20, 2012

Last Update Submit

October 20, 2015

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • Weight Gain

    Mean weight gain (g/day) from enrollment to 4 months of age

    4 months

Secondary Outcomes (1)

  • tolerance

    4 months

Study Arms (2)

Amino Acid Formula

EXPERIMENTAL

Hypoallergenic baby formula

Other: Amino Acid Formula

Amino Acid commercial formula

ACTIVE COMPARATOR

Hypoallergenic commercial amino acid formula

Other: Amino Acid formula

Interventions

Amino Acid formulaOTHER

Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula

Amino Acid Formula

Eligibility Criteria

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

You may qualify if:

  • Healthy newborn infant
  • Full-term (\>= 37 weeks gestation)
  • Birth weight between \>= 2500 and \< =4500 g
  • days of age on enrolment (day 0 is day of birth)
  • Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
  • Study explained and written information provided with Caregiver demonstrating understanding of the given information
  • Informed consent signed (parent/legal representative)

You may not qualify if:

  • Congenital illness or malformation that may affect infant feeding and/or normal growth
  • Suspected or known allergy to cow's milk protein
  • Significant pre-natal and/or post-natal disease
  • Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
  • Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
  • Infant currently participating in another conflicting clinical study
  • Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35205, United States

Location

Alabama Clinical Therapeutics/Southlake Pediatrics

Birmingham, Alabama, 35244, United States

Location

Clinical Research Consortium Arizona

Phoenix, Arizona, 85004, United States

Location

Lutheran General Children's Hospital

Park Ridge, Illinois, 60068, United States

Location

Nassim, MCMonigle, Mescia and Associates

New Albany, Indiana, 47150, United States

Location

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, 40291, United States

Location

Southwestern Medical Clinic

Niles, Michigan, 49120, United States

Location

Southwestern Medical Clinic

Stevensville, Michigan, 49127, United States

Location

Women's Clinic of Lincoln, P.C.

Lincoln, Nebraska, 68510, United States

Location

Blue Ridge Pediatric and Adolescent Medicine, Inc.

Boone, North Carolina, 28607, United States

Location

Haywood Pediatric and Adolescent Medicine Group, P.A.

Clyde, North Carolina, 28721, United States

Location

Tarheel Clinical Research

Raleigh, North Carolina, 27612, United States

Location

Ohio Pediatric Research Assn.

Dayton, Ohio, 45414, United States

Location

Institute of Clinical Research

Mayfield Heights, Ohio, 44124, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Clinical Research Specialists of Utah, Inc

Spanish Fork, Utah, 84660, 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

Study Officials

  • Marc Corkins, MD

    Le Bonheur Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 24, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 21, 2015

Record last verified: 2014-06

Locations

US(17)