Adherence With Iron Sprinkles Among High-Risk Infants

Centers for Disease Control and Prevention128 enrolled

Overview

Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.

Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high. Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

128

Conditions

Anemia Iron Deficiency

Interventions

Ferrous sulphate drops with vitamins A, D, and CDRUG

Ferrous fumarate sprinkles with vitamins and mineralsDRUG

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 7 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy infants * Age 5-7 months * Presenting for 6 months well-child care * Caregiver speaks English or Spanish Exclusion Criteria: * Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection) * Inability to speak English or Spanish * Use of vitamin or iron supplements in the previous three months

Locations (2)

Whittier Street Health Center

Boston, Massachusetts, United States

Boston Medical Center Pediatric Primary Care Clinic

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

full adherence, use of iron supplements 6-7 days/week for 3 months

Secondary Outcomes

iron deficiency at 9 months of age

anemia at 9 months of age

Data from ClinicalTrials.gov

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