Boston, Massachusetts 02108

  • Iron Deficiency

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDC-NCCDPHP-MM-0835-O5/05


NCT ID:

NCT00136266


Secondary ID:

CDC-MM-0835-O5/05


Study Acronym:


Brief Title:

Adherence With Iron Sprinkles Among High-Risk Infants


Official Title:

Adherence With Iron Sprinkles Among High-Risk Infants


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

5 Months


Maximum Age:

7 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Centers for Disease Control and Prevention


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

128


Enrollment Type:

Actual


Overall Contact Information

Official Name:Paul L. Geltman, MD, MPH
Principal Investigator
Boston University

Study Dates

Start Date:March 2005
Completion Date:December 2005
Completion Type:Actual
Primary Completion Date:December 2005
Primary Completion Type:Actual
Verification Date:September 2007
Last Changed Date:February 2, 2016
First Received Date:August 25, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:full adherence, use of iron supplements 6-7 days/week for 3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:iron deficiency at 9 months of age
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:anemia at 9 months of age
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ferrous sulphate drops with vitamins A, D, and C
Intervention Type:Drug
Name:Ferrous fumarate sprinkles with vitamins and miner

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Centers for Disease Control and Prevention

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:19111318

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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