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

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.
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
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferrous gluconate and iron polysaccharide complex Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2007
Estimated Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy toddlers age 9-18 months

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Jacob Urkin, MD, MPH 972-8-6477480 jacobur@clalit.org.il

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: Dr Jacob Urkin, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00248716     History of Changes
Other Study ID Numbers: sor458607ctil
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferrous gluconate
Iron
Hematinics
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs