drugset / Trial / NCT00248716

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

NCT00248716

Phase 4 Unknown 200 enrolled Soroka University Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-02
Primary completion
2009-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject FERROUS GLUCONATE ANHYDROUS Small molecule 5 mg/kg
Subject iron polysaccharide complex Unknown 5 mg/kg