Adherence With Iron Sprinkles Among High-Risk Infants

This study has been completed.

Sponsor:

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00136266

First received: August 25, 2005

Last updated: February 2, 2016

Last verified: September 2007

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Adherence With Iron Sprinkles Among High-Risk Infants

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron Minerals

Drug Information available for: Ferrous fumarate Vitamin A

U.S. FDA Resources

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


Enrollment:	128
Study Start Date:	March 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators


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

More Information

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.


ClinicalTrials.gov Identifier:	NCT00136266 History of Changes
Other Study ID Numbers:	CDC-NCCDPHP-MM-0835-O5/05 CDC-MM-0835-O5/05
Study First Received:	August 25, 2005
Last Updated:	February 2, 2016
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:


Adherence Supplements Iron Iron deficiency	Anemia Vitamins Minerals

Additional relevant MeSH terms:


Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases Vitamins Vitamin A	Vitamin D Ferrous fumarate Micronutrients Growth Substances Physiological Effects of Drugs Trace Elements Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2016

To Top