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Growth of Infants Fed an Elemental Medical Food

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ClinicalTrials.gov Identifier: NCT01699386
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Healthy Infants Other: Control Study Formula Other: Experimental Study Formula Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth of Infants Fed an Elemental Medical Food
Study Start Date : April 1999
Actual Primary Completion Date : December 2000
Actual Study Completion Date : December 2000

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Weight [ Time Frame: 14 days of age to 112 days of age ]
    weight gain during the study period


Secondary Outcome Measures :
  1. Anthropometric Measurements [ Time Frame: 14 days of age to 112 days of age ]
    length, head circumference, and length gain

  2. GI Tolerance [ Time Frame: At visits 14 and 28 ]
    daily stool number, stool consistency, formula intake

  3. Lab Measurement [ Time Frame: At 112 day visit ]
    serum albumin



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Ages Eligible for Study:   up to 9 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01699386     History of Changes
Other Study ID Numbers: AH73
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012