Back to resultsPrevention of Iron Deficiency in 2nd Year of Life
Primary Purpose
Iron Deficiency, Anemia
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Ferripel-3 - iron polysaccharide complex for prevention
Sponsored by
About this trial
This is an interventional prevention trial for Iron Deficiency focused on measuring Iron supplementation, Babies, Prevention
Eligibility Criteria
Inclusion Criteria:
- Healthy babies without iron deficiency
Exclusion Criteria:
- Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease
Sites / Locations
- Clalit Health Services Child Health Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00479102
First Posted
May 24, 2007
Last Updated
May 24, 2007
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00479102
Brief Title
Prevention of Iron Deficiency in 2nd Year of Life
Official Title
Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group. Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anemia
Keywords
Iron supplementation, Babies, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ferripel-3 - iron polysaccharide complex for prevention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy babies without iron deficiency
Exclusion Criteria:
Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Shalev, MD
Phone
972-52-8504058
Email
hannash@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Shalev, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Services Child Health Center
City
Rahat
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Shalev, MD
Phone
972-52-8504058
Email
hannash@clalit.org.il
12. IPD Sharing Statement
Learn more about this trial
Prevention of Iron Deficiency in 2nd Year of Life
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