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OpenTrials
Completed

NCT Number: NCT01497314

Growth and Safety of a Low Lactose Milk-Based Infant Formula

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

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Key information

Conditions

Growth Healthy Term Infants

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Accelovance Melbourne Site, Melbourne, Florida, United States

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About this study

Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy term infants
  • birth weight 2500 - 4500 g
  • singleton birth
  • 37 - 42 weeks gestation

Exclusion criteria

  • clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
  • receiving medications other than vitamins

Treatment and study plan

Low Lactose Infant Formula

Other

Low Lactose Infant Formula

Primary outcomes

  1. Weight

    Time frame: 16 weeks

Secondary outcomes

  1. Length gain

    Time frame: 16 weeks

  2. Occipital Head Circumference

    Time frame: 16 weeks

  3. Acceptability and Tolerability

    Time frame: 16 weeks

    Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications

Sponsors and collaborators

Lead sponsor

Perrigo Nutritionals

Industry

Registry information

Official study title

An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 22, 2011
Registry last updated
May 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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