Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.

This study is currently recruiting participants.

Verified by Soroka University Medical Center, April 2008

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00248716

Purpose

Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:

Iron deficiency with no anemia
anemia
no anemia and no iron deficiency Following a nutritional questionnaire, parents of all toddlers will receive instruction regarding appropriate nutrition in the 2nd year of life. Groups 1 and 2 will randomly receive one of two preparations currently in use for treatment of iron deficiency in Israel (Aktiron 35 - Ferrous gluconate and Ferripel-3 - iron polysaccharide complex). Followup blood count will be taken 3 month after recruitment. The study aims to compare the effectiveness of the Iron preparations regarding compliance and efficacy.

The hypothesis is that a significant difference will be detected between the two preparations.

Condition	Intervention	Phase
Iron Deficiency Anemia	Drug: Ferrous gluconate and iron polysaccharide complex	Phase IV

MedlinePlus related topics: Anemia

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

Estimated Enrollment:	200
Study Start Date:	February 2007
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248716

Contacts

Contact: Jacob Urkin, MD, MPH

972-8-6477480

Locations

Israel
Primary Pediatric Care Unit, Ben-Gurion University of the Negev	Recruiting
Beer-Sheva, Israel, 84105
Contact: Jacob Urkin, MD, MPH 972-8-6477480 jacobur@clalit.org.il

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator:

Jacob Urkin, MD, MPH

Ben-Gurion University of the Negev

More Information

Responsible Party:	Ben-Gurion University of the Negev ( Dr Jacob Urkin )
Study ID Numbers:	sor458607ctil
Study First Received:	November 3, 2005
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00248716
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Metabolic Diseases
Hematologic Diseases
Ferrous gluconate
Anemia

Iron Metabolism Disorders
Metabolic disorder
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents

Anemia, Hypochromic
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009