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Adherence With Iron Sprinkles Among High-Risk Infants

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00136266
First received: August 25, 2005
Last updated: September 20, 2007
Last verified: September 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Anemia
Iron Deficiency
 Drug: Ferrous sulphate drops with vitamins A, D, and C
Drug: Ferrous fumarate sprinkles with vitamins and minerals
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adherence With Iron Sprinkles Among High-Risk Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • full adherence, use of iron supplements 6-7 days/week for 3 months

Secondary Outcome Measures:
  • iron deficiency at 9 months of age
  • anemia at 9 months of age

Estimated Enrollment: 128
Study Start Date: March 2005
Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   5 Months to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136266

Locations
United States, Massachusetts
Boston Medical Center Pediatric Primary Care Clinic
Boston, Massachusetts, United States, 02118
Whittier Street Health Center
Boston, Massachusetts, United States, 02108
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Paul L. Geltman, MD, MPH Boston University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136266     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-MM-0835-O5/05, CDC-MM-0835-O5/05
Study First Received: August 25, 2005
Last Updated: September 20, 2007
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Adherence
Supplements
Iron
Iron deficiency
 Anemia
Vitamins
Minerals

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Vitamin A
Vitamins
 Vitamin D
Ferrous fumarate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Trace Elements
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 22, 2013