Adherence With Iron Sprinkles Among High-Risk Infants

Phase 3

Completed

• Conditions: Anemia; Iron Deficiency

• Registration Number: NCT00136266
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2007-09
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
anemia at 9 months of age
iron deficiency at 9 months of age

Trial Locations

Locations (2)

Whittier Street Health Center; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center Pediatric Primary Care Clinic; 🇺🇸 Boston, Massachusetts, United States