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Prevention of Iron Deficiency in 2nd Year of Life

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: NCT00479102
Recruitment Status : Unknown
Verified May 2007 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2007
Last Update Posted : May 25, 2007
Sponsor:
Information provided by:
Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferripel-3 - iron polysaccharide complex for prevention Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron





Information from the National Library of Medicine

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Ages Eligible for Study:   8 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT00479102


Contacts
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Contact: Hanna Shalev, MD 972-52-8504058 hannash@clalit.org.il

Locations
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Israel
Clalit Health Services Child Health Center
Rahat, Israel
Contact: Hanna Shalev, MD    972-52-8504058    hannash@clalit.org.il   
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Hanna Shalev, MD Clalit Health Services
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ClinicalTrials.gov Identifier: NCT00479102    
Other Study ID Numbers: sor448707ctil
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007
Keywords provided by Soroka University Medical Center:
Iron supplementation
Babies
Prevention
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases