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OpenTrials
Completed

NCT Number: NCT01617889

Healthy Term Infants Fed Milk-Based Formulas

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

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Key information

Conditions

Healthy Term Infant

Age range

53 day–115 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Infant is judged to be in good health.
  • Infant is singleton from a full term birth
  • Infant's birth weight was > 2490 g.
  • Infant is between 53 and 115 days of age
  • Infant is on infant formula and tolerating infant formula feedings
  • Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
  • Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion criteria

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

Treatment and study plan

Experimental powdered milk-based infant formula with an alternate fat blend

Other

formula to be consumed ad lib

A powdered milk-based infant formula, standard fat blend

Other

formula to be consumed ad lib

Primary outcomes

  1. calcium absorption

    Time frame: 8 days

    as measured in stool

Secondary outcomes

  1. stool consistency

    Time frame: 28 days

    measured on 5 point scale

  2. fat absorption

    Time frame: 8 days

    as measured in stool

  3. average number of stools per day

    Time frame: 28 days

  4. percent of feedings with spit up/vomit associated with feeding per day.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2012
Registry last updated
Feb 15, 2013

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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