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Prevention of Iron Deficiency in 2nd Year of Life

Sponsor
Soroka University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00479102
Collaborator
(none)
1
Location

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ferripel-3 - iron polysaccharide complex for prevention
 Phase 4

Study Design

Study Type:
Interventional
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 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Months to 18 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy babies without iron deficiency
    Exclusion Criteria:
    • Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clalit Health Services Child Health Center Rahat Israel

    Sponsors and Collaborators

    • Soroka University Medical Center

    Investigators

    • Principal Investigator: Hanna Shalev, MD, Clalit Health Services

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00479102
    Other Study ID Numbers:
    • sor448707ctil
    First Posted:
    May 25, 2007
    Last Update Posted:
    May 25, 2007
    Last Verified:
    May 1, 2007
    Keywords provided by , ,
    Iron supplementation
    Babies
    Prevention
    Additional relevant MeSH terms:
    Anemia, Iron-Deficiency

    Study Results

    No Results Posted as of May 25, 2007