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Adherence With Iron Sprinkles Among High-Risk Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00136266
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : February 3, 2016
Sponsor:
Information provided by:
Centers for Disease Control and Prevention

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adherence With Iron Sprinkles Among High-Risk Infants
Study Start Date : March 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. full adherence, use of iron supplements 6-7 days/week for 3 months

Secondary Outcome Measures :
  1. iron deficiency at 9 months of age
  2. anemia at 9 months of age

Eligibility Criteria
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Ages Eligible for Study:   5 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136266


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

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ClinicalTrials.gov Identifier: NCT00136266    
Other Study ID Numbers: CDC-NCCDPHP-MM-0835-O5/05
CDC-MM-0835-O5/05
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: September 2007
Keywords provided by Centers for Disease Control and Prevention:
Adherence
Supplements
Iron
Iron deficiency
 Anemia
Vitamins
Minerals
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Vitamin D
 Vitamins
Vitamin A
Ferrous fumarate
Micronutrients
Physiological Effects of Drugs
Trace Elements
Bone Density Conservation Agents