Prevention of Iron Deficiency in Breastfed Infants

United States Department of Health and Human Services (HHS)

Status and phase: Completed; Phase 4

Conditions: Anemia; Iron Deficiency

Treatments: Dietary Supplement: Fer-in-Sol; Other: control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01444261

BFe10D

Details and patient eligibility

About

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

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 4 weeks to 9 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Fer-in-Sol drops and iron-fortified cereal

Treatment:

Dietary Supplement: Fer-in-Sol

Control

Other group

Description:

No intervention

Treatment:

Other: control