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Completed

NCT Number: NCT00941564

Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends

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

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Key information

Conditions

Infant

Age range

84 day–159 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics, Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
  • Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.

Exclusion criteria

  • Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Infant has been treated with antibiotics 3 days prior to enrollment.
  • Infant has received probiotics-containing products 3 days prior to enrollment.

Treatment and study plan

Infant Formula milk based

Other

Consume ad lib

Primary outcomes

  1. Calcium absorption

    Time frame: 18 days

Secondary outcomes

  1. Calcium retention, fat absorption, tolerance

    Time frame: 18 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

"Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2009
Registry last updated
Nov 25, 2010

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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