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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:

U.S. FDA Resources

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
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 May 16, 2013