Adherence With Iron Sprinkles Among High-Risk Infants

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00136266

Enrollment

128

Registered

2005-08-29

Start date

2005-03-31

Completion date

2005-12-31

Last updated

2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron Deficiency

Keywords

Adherence, Supplements, Iron, Iron deficiency, Anemia, Vitamins, Minerals

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.

Interventions

DRUGFerrous sulphate drops with vitamins A, D, and C

DRUGFerrous fumarate sprinkles with vitamins and minerals

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Months to 7 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
iron deficiency at 9 months of age	—
anemia at 9 months of age	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026