Growth of Infants Fed an Elemental Medical Food

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01699386
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy Infants
Other: Control Study Formula
Other: Experimental Study Formula
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth of Infants Fed an Elemental Medical Food

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight [ Time Frame: 14 days of age to 112 days of age ] [ Designated as safety issue: No ]
    weight gain during the study period


Secondary Outcome Measures:
  • Anthropometric Measurements [ Time Frame: 14 days of age to 112 days of age ] [ Designated as safety issue: No ]
    length, head circumference, and length gain

  • GI Tolerance [ Time Frame: At visits 14 and 28 ] [ Designated as safety issue: No ]
    daily stool number, stool consistency, formula intake

  • Lab Measurement [ Time Frame: At 112 day visit ] [ Designated as safety issue: No ]
    serum albumin


Enrollment: 213
Study Start Date: April 1999
Study Completion Date: December 2000
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Study Formula
protein hydrolysate formula
Other: Control Study Formula
feed as lib
Other Names:
  • protein hydrolysate formula
  • Nutramigen
Experimental: Experimental Study Formula
free-amino acid-based medical food
Other: Experimental Study Formula
feed as lib
Other Names:
  • free-amino acid-based medical food
  • EleCare

  Eligibility

Ages Eligible for Study:   up to 9 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Maternal, fetal or perinatal history which may have adverse effects on growth
  • Multiple birth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699386

Locations
United States, Arkansas
T&W Research
Little Rock, Arkansas, United States, 72211
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242-1083
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Marlene W Borschel, PhD, RD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01699386     History of Changes
Other Study ID Numbers: AH73
Study First Received: October 2, 2012
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014