Adherence With Iron Sprinkles Among High-Risk Infants

Centers for Disease Control and Prevention (CDC)

Status and phase

Completed

Phase 3

Conditions

Anemia

Iron Deficiency

Treatments

Drug: Ferrous sulphate drops with vitamins A, D, and C

Drug: Ferrous fumarate sprinkles with vitamins and minerals

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00136266

CDC-NCCDPHP-MM-0835-O5/05

CDC-MM-0835-O5/05

Details and patient eligibility

About

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.

Full description

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.

Enrollment

128 patients

Sex

All

Ages

5 to 7 months old

Volunteers

Accepts Healthy Volunteers

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