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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Soroka University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248716
First Posted: November 4, 2005
Last Update Posted: May 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
November 3, 2005
November 4, 2005
May 6, 2008
February 2007
April 2009   (Final data collection date for primary outcome measure)
Hemoglobin [ Time Frame: 3 months ]
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Complete list of historical versions of study NCT00248716 on ClinicalTrials.gov Archive Site
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Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
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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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Iron Deficiency
  • Anemia
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
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April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy toddlers age 9-18 months

Exclusion Criteria:

  • Toddlers with: chronic diseases, prematurity, inherited hematological disease.
Sexes Eligible for Study: All
9 Months to 18 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00248716
sor458607ctil
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Dr Jacob Urkin, Ben-Gurion University of the Negev
Soroka University Medical Center
Not Provided
Principal Investigator: Jacob Urkin, MD, MPH Ben-Gurion University of the Negev
Soroka University Medical Center
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP