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OpenTrials
Completed

NCT Number: NCT00136266

Adherence With Iron Sprinkles Among High-Risk Infants

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boston Medical Center Pediatric Primary Care Clinic, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous sulphate drops with vitamins A, D, and C

Drug

Ferrous fumarate sprinkles with vitamins and minerals

Drug

Primary outcomes

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

Secondary outcomes

  1. iron deficiency at 9 months of age

  2. anemia at 9 months of age

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Aug 29, 2005
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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