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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:
Soroka University Medical Center

Tracking Information
First Submitted Date  ICMJE November 3, 2005
First Posted Date  ICMJE November 4, 2005
Last Update Posted Date May 6, 2008
Study Start Date  ICMJE February 2007
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Hemoglobin [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Iron Deficiency
  • Anemia
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 18, 2007)
200
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy toddlers age 9-18 months

Exclusion Criteria:

  • Toddlers with: chronic diseases, prematurity, inherited hematological disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00248716
Other Study ID Numbers  ICMJE sor458607ctil
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Jacob Urkin, Ben-Gurion University of the Negev
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacob Urkin, MD, MPH Ben-Gurion University of the Negev
PRS Account Soroka University Medical Center
Verification Date April 2008

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