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OpenTrials
Completed

NCT Number: NCT01699386

Growth of Infants Fed an Elemental Medical Food

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

Completed

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Key information

Conditions

Healthy Infants

Age range

Up to 9 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

T&W Research, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Study Formula

Other

feed as lib

Other names: protein hydrolysate formula, Nutramigen

Experimental Study Formula

Other

feed as lib

Other names: free-amino acid-based medical food, EleCare

Primary outcomes

  1. Weight

    Time frame: 14 days of age to 112 days of age

    weight gain during the study period

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
First posted
Oct 3, 2012
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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