Ferrous sulphate drops with vitamins A, D, and C and Ferrous fumarate sprinkles with vitamins and minerals in Anemia and Iron Deficiency - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

128

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
full adherence, use of iron supplements 6-7 days/week for 3 months

Secondary Outcome Measures

Outcome Measure
iron deficiency at 9 months of age
anemia at 9 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria