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History of Changes for Study: NCT00136266
Adherence with Iron Sprinkles Among High-Risk Infants
Latest version (submitted February 2, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 25, 2005 None (earliest Version on record)
2 November 17, 2005 Outcome Measures, Study Description, Study Identification, Eligibility, Conditions and Study Status
3 December 12, 2005 Study Status
4 September 20, 2007 Recruitment Status, Study Status, Contacts/Locations, Study Design, Oversight and Study Identification
5 February 2, 2016 Study Status, References, Study Design and Oversight
Comparison Format:

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Study NCT00136266
Submitted Date:  August 25, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDC-NCCDPHP-9999
Brief Title: Adherence with Iron Sprinkles Among High-Risk Infants
Official Title: Adherence with Iron Sprinkles Among High-Risk Infants
Secondary IDs: CDC-MM-0835-O5/05
Open or close this module Study Status
Record Verification: August 2005
Overall Status: Recruiting
Study Start: March 2005
Primary Completion:
Study Completion: December 2005
First Submitted: August 25, 2005
First Submitted that
Met QC Criteria:
August 25, 2005
First Posted: August 29, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 25, 2005
Last Update Posted: August 29, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Centers for Disease Control and Prevention
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Anemia
Iron deficiency
Keywords: Adherence
Supplements
Iron
Iron deficiency
Anemia
Vitamins
Minerals
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 128
Open or close this module Arms and Interventions
Intervention Details:
Drug: Ferrous sulphate drops with vitamins A, D, and C
Drug: Ferrous fumarate sprinkles with vitamins and minerals
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 5 Months
Maximum Age: 7 Months
Sex: All
Gender Based:
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 malabsoprtion, 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
Open or close this module Contacts/Locations
Central Contact Person: Paul L Geltman, MD, MPH
Telephone: 617-414-4233
Email: pgeltman@bu.edu
Study Officials: Paul L. Geltman, MD, MPH
Principal Investigator
Boston University
Locations: United States, Massachusetts
Whittier Street Health Center
[Recruiting]
Boston, Massachusetts, United States, 02108
Boston Medical Center Pediatric Primary Care Clinic
[Recruiting]
Boston, Massachusetts, United States, 02118
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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