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OpenTrials
Completed

NCT Number: NCT00760890

Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.

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Key information

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fomon Infant Nutrition Unit

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

  • Predominantly breastfed (at 4 months) term infants

Exclusion criteria

  • Not predominantly breastfed at 4 months
  • Premature infants

Treatment and study plan

Fer-In-Sol (ferrous sulfate)

Dietary Supplement

7.5 mg/day in the form of 0.3 ml once each day

Iron fortified cereal

Dietary Supplement

1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.

Primary outcomes

  1. Iron status

    Time frame: 3 times during the intervention

Secondary outcomes

  1. Growth

    Time frame: At the end of intervention

  2. Tolerance (gastrointestinal)

    Time frame: During intervention

Sponsors and collaborators

Lead sponsor

National Institutes of Health (NIH)

Nih

Registry information

Acronym: BFe01B1

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 26, 2008
Registry last updated
Sep 26, 2008

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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