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Completed

NCT Number: NCT00841061

Cereals as a Source of Iron for Breastfed Infants

The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

28 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • exclusively breastfed
  • birth weight between 2500 and 4200g
  • gestational age >36 weeks

Exclusion criteria

  • supplementing formula
  • no iron drops

Treatment and study plan

electrolytic iron

Dietary Supplement

1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age

ferrous fumarate

Dietary Supplement

1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age

Primary outcomes

  1. plasma ferritin

    Time frame: 280 days

Secondary outcomes

  1. hemoglobin

    Time frame: 280

Sponsors and collaborators

Lead sponsor

National Institutes of Health (NIH)

Nih

Registry information

Official study title

Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron

Acronym: Bfe03B

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Feb 11, 2009
Registry last updated
Feb 11, 2009

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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