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

Phase 4

• Conditions: Iron Deficiency; Anemia

• Registration Number: NCT00248716
• Lead Sponsor: Soroka University Medical Center

Brief Summary

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

1. Iron deficiency with no anemia

2. anemia

3. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-04
• Study Start: 2007-02
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-29
• Last Update Posted: 2008-05-06
• Primary Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Healthy toddlers age 9-18 months

Exclusion Criteria

• Toddlers with: chronic diseases, prematurity, inherited hematological disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin	3 months

Trial Locations

Locations (1)

Primary Pediatric Care Unit, Ben-Gurion University of the Negev; 🇮🇱 Beer-Sheva, Israel