Back to resultsTreatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
Primary Purpose
Iron Deficiency, Anemia
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Ferrous gluconate and iron polysaccharide complex
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency
Eligibility Criteria
Inclusion Criteria: Healthy toddlers age 9-18 months Exclusion Criteria: Toddlers with: chronic diseases, prematurity, inherited hematological disease.
Sites / Locations
- Primary Pediatric Care Unit, Ben-Gurion University of the NegevRecruiting
Outcomes
Primary Outcome Measures
Hemoglobin
Secondary Outcome Measures
Full Information
NCT ID
NCT00248716
First Posted
November 3, 2005
Last Updated
April 29, 2008
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00248716
Brief Title
Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
5. Study Description
Brief Summary
Healthy toddlers (age 9-18 month) following a routine blood count will be placed in three groups:
Iron deficiency with no anemia
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ferrous gluconate and iron polysaccharide complex
Intervention Description
Children with anemia will receive 5mg per kg per day of one of study medications. Treatment period for 3 months
Primary Outcome Measure Information:
Title
Hemoglobin
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy toddlers age 9-18 months
Exclusion Criteria:
Toddlers with: chronic diseases, prematurity, inherited hematological disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Urkin, MD, MPH
Phone
972-8-6477480
Email
jacobur@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Urkin, MD, MPH
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Pediatric Care Unit, Ben-Gurion University of the Negev
City
Beer-Sheva
ZIP/Postal Code
84105
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Urkin, MD, MPH
Phone
972-8-6477480
Email
jacobur@clalit.org.il
12. IPD Sharing Statement
Learn more about this trial
Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
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