Back to resultsAdherence With Iron Sprinkles Among High-Risk Infants
Primary Purpose
Anemia, Iron Deficiency
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferrous sulphate drops with vitamins A, D, and C
Ferrous fumarate sprinkles with vitamins and minerals
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring Adherence, Supplements, Iron, Iron deficiency, Anemia, Vitamins, Minerals
Eligibility 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
Sites / Locations
- Whittier Street Health Center
- Boston Medical Center Pediatric Primary Care Clinic
Outcomes
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
Full Information
NCT ID
NCT00136266
First Posted
August 25, 2005
Last Updated
February 2, 2016
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00136266
Brief Title
Adherence With Iron Sprinkles Among High-Risk Infants
Official Title
Adherence With Iron Sprinkles Among High-Risk Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency
Keywords
Adherence, Supplements, Iron, Iron deficiency, Anemia, Vitamins, Minerals
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ferrous sulphate drops with vitamins A, D, and C
Intervention Type
Drug
Intervention Name(s)
Ferrous fumarate sprinkles with vitamins and minerals
Primary Outcome Measure Information:
Title
full adherence, use of iron supplements 6-7 days/week for 3 months
Secondary Outcome Measure Information:
Title
iron deficiency at 9 months of age
Title
anemia at 9 months of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul L. Geltman, MD, MPH
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whittier Street Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02108
Country
United States
Facility Name
Boston Medical Center Pediatric Primary Care Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19111318
Citation
Geltman PL, Hironaka LK, Mehta SD, Padilla P, Rodrigues P, Meyers AF, Bauchner H. Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops. J Pediatr. 2009 May;154(5):738-43. doi: 10.1016/j.jpeds.2008.11.003. Epub 2008 Dec 25.
Results Reference
result
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Adherence With Iron Sprinkles Among High-Risk Infants
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