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Adherence With Iron Sprinkles Among High-Risk Infants

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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

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE March 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
full adherence, use of iron supplements 6-7 days/week for 3 months
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
-full adherence, use of iron supplements 6-7 days/week for 3 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
  • iron deficiency at 9 months of age
  • anemia at 9 months of age
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
  • -iron deficiency at 9 months of age.
  • -anemia at 9 months of age.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence With Iron Sprinkles Among High-Risk Infants
Official Title  ICMJE Adherence With Iron Sprinkles Among High-Risk Infants
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Anemia
  • Iron Deficiency
Intervention  ICMJE
  • Drug: Ferrous sulphate drops with vitamins A, D, and C
  • Drug: Ferrous fumarate sprinkles with vitamins and minerals
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2005)
128
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Months to 7 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136266
Other Study ID Numbers  ICMJE CDC-NCCDPHP-MM-0835-O5/05
CDC-MM-0835-O5/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centers for Disease Control and Prevention
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul L. Geltman, MD, MPH Boston University
PRS Account Centers for Disease Control and Prevention
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP