Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
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|ClinicalTrials.gov Identifier: NCT00248716|
Recruitment Status : Unknown
Verified April 2008 by Soroka University Medical Center.
Recruitment status was: Recruiting
First Posted : November 4, 2005
Last Update Posted : May 6, 2008
Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:
- Iron deficiency with no 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 or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Drug: Ferrous gluconate and iron polysaccharide complex||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2007|
|Estimated Primary Completion Date :||April 2009|
- Drug: Ferrous gluconate and iron polysaccharide complex
Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months
- Hemoglobin [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248716
|Contact: Jacob Urkin, MD, MPHfirstname.lastname@example.org|
|Primary Pediatric Care Unit, Ben-Gurion University of the Negev||Recruiting|
|Beer-Sheva, Israel, 84105|
|Contact: Jacob Urkin, MD, MPH 972-8-6477480 email@example.com|
|Principal Investigator:||Jacob Urkin, MD, MPH||Ben-Gurion University of the Negev|