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Adherence With Iron Sprinkles Among High-Risk Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00136266
First Posted: August 29, 2005
Last Update Posted: February 3, 2016
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.
Information provided by:
Centers for Disease Control and Prevention
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adherence With Iron Sprinkles Among High-Risk Infants

Resource links provided by NLM:


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

Enrollment: 128
Study Start Date: March 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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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
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
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
Principal Investigator: Paul L. Geltman, MD, MPH Boston University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00136266     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-MM-0835-O5/05
CDC-MM-0835-O5/05
First Submitted: August 25, 2005
First Posted: August 29, 2005
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:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin A
Vitamin D
Iron
Ferrous fumarate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Bone Density Conservation Agents