Prevention of Iron Deficiency in Breastfed Infants

Anemia Clinical Trial

Official title:

Prevention of Iron Deficiency in Breastfed Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444261
• Other study ID #: BFe10D
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2011
• Last updated: March 29, 2017
• Start date: December 2010
• Est. completion date: April 2014

Study information

• Verified date: March 2017
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• Fer-in-Sol
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

Other:
• control
No dietary supplements

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron deficiency anemia will be prevented in all infants before 5.5 mo of age	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.	5.5 mo
Secondary	Determine the number of infants with iron deficiency between 5.5 and 9 mo of age	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	9 mo