Adherence With Iron Sprinkles Among High-Risk Infants - Full Text View

Sponsored by:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00136266

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 III

MedlinePlus related topics: Anemia Minerals

Drug Information available for: Vitamin A Retinol Ferrous sulfate Ferrous fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Adherence With Iron Sprinkles Among High-Risk Infants

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

Estimated Enrollment:	128
Study Start Date:	March 2005
Study Completion Date:	December 2005

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

Ages Eligible for Study:	5 Months to 7 Months
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136266

Locations

United States, Massachusetts
Boston Medical Center Pediatric Primary Care Clinic
Boston, Massachusetts, United States, 02118
Whittier Street Health Center
Boston, Massachusetts, United States, 02108

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Paul L. Geltman, MD, MPH

Boston University

More Information

Study ID Numbers:	CDC-NCCDPHP-MM-0835-O5/05, CDC-MM-0835-O5/05
Study First Received:	August 25, 2005
Last Updated:	September 20, 2007
ClinicalTrials.gov Identifier:	NCT00136266
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Adherence
Supplements
Iron
Iron deficiency

Anemia
Vitamins
Minerals

Study placed in the following topic categories:

Ferrous fumarate
Metabolic Diseases
Retinol palmitate
Hematologic Diseases
Vitamin A

Anemia
Iron Metabolism Disorders
Metabolic disorder
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Anemia, Hypochromic

Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009