Prevention of Iron Deficiency in Breastfed Infants

Phase 4

Completed

• Conditions: Iron Deficiency; Anemia
• Interventions: Dietary Supplement: Fer-in-Sol; Other: control

• Registration Number: NCT01444261
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-30
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Fer-in-Sol	Fer-in-Sol drops and iron-fortified cereal
Control	control	No intervention

Primary Outcome Measures

Name	Time	Method
Iron deficiency anemia will be prevented in all infants before 5.5 mo of age	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 Outcome Measures

Name	Time	Method
Determine the number of infants with iron deficiency between 5.5 and 9 mo of age	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

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States