Clinical Trial: Prevention of Iron Deficiency in Breastfed Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prevention of Iron Deficiency in Breastfed Infants

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

Detailed Summary: 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.
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

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

Dates:
Date Received: September 28, 2011
Date Started: December 2010
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017