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Completed

NCT Number: NCT01444261

Prevention of Iron Deficiency in Breastfed Infants

With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

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Key information

Conditions

Iron Deficiency Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 week–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Term infants
  • gestational age 37-42 weeks
  • birth weight > 2500 g
  • exclusively breastfed at 28 d of age
  • intend to breast feed until 9 mo of age

Exclusion criteria

  • supplemental formula before 4 mo of age

Treatment and study plan

Fer-in-Sol

Dietary Supplement

Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal

Control

Other

No dietary supplements

Primary outcomes

  1. Iron deficiency anemia will be prevented in all infants before 5.5 mo of age

    Time frame: 5.5 mo

    Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.

Secondary outcomes

  1. Determine the number of infants with iron deficiency between 5.5 and 9 mo of age

    Time frame: 9 mo

    Iron deficiency will be determined as plasma ferritin less than 10 ug/L. We will determine the number of infants with iron deficiency between 5.5 and 9 mo of age

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

  • University of Iowa

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 30, 2011
Registry last updated
Mar 31, 2017

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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